Z-2341-2017Class II
VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton
bioMerieux, Inc. / initiated 2017-04-20 / Terminated / root cause: packaging
Biomerieux Inc began a recall of VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton on . FDA classified it as Class II and gives the reason as "The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency)". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2341-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- bioMerieux, Inc.
- Product
- VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
- Product code
- LQM Gram Negative Identification Panel
- Reason for recall
- The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
- Quantity in commerce
- 177,828 cartons
- Distribution
- Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
- Product codes and lots
- 241396010 17/Oct/17 241398120 07/Nov/17 241398420 10/Nov/17 241398620 12/Nov/17 241398720 13/Nov/17 241398820 14/Nov/17 241399520 21/Nov/17 2410000203 26/Nov/17 2410002203 28/Nov/17 2410006203 02/Dec/17 2410007203 03/Dec/17 2410008203 04/Dec/17 2410009103 05/Dec/17 2410031103 27/Dec/17 2410033103 29/Dec/17 2410034103 30/Dec/17 2410037103 02/Jan/18 2410038103 03/Jan/18 2410041103 06/Jan/18 2410042103 07/Jan/18 2410043103 08/Jan/18 2410044203 09/Jan/18 2410047203 12/Jan/18 2410052103 17/Jan/18 2410057103 22/Jan/18 2410058103 23/Jan/18 2410063103 28/Jan/18 2410064103 29/Jan/18 2410065103 30/Jan/18 2410071103 05/Feb/18 2410072103 06/Feb/18 2410078103 12/Feb/18 2410083103 17/Feb/18 2410085203 19/Feb/18 2410086103 20/Feb/18 2410088103 22/Feb/18 2410091203 25/Feb/18 2410092103 26/Feb/18 2410093103 27/Feb/18 2410097103 03/Mar/18 2410098103 04/Mar/18 2410099103 05/Mar/18 2410100103 06/Mar/18 2410105203 11/Mar/18 2410106103 12/Mar/18 2410107203 13/Mar/18
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2341-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2342-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2343-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2344-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2345-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2346-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2347-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2348-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2349-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2350-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2351-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2352-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2353-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2354-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2355-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2356-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2357-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2358-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2359-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2360-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2361-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2362-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2363-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2364-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2365-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2366-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2367-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2368-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2369-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2370-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2371-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2372-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2373-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2374-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2375-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2376-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2377-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2378-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2379-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2380-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2381-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2382-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2383-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2384-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2385-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2386-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2387-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2388-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2389-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2390-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2391-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2392-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2393-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2394-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2395-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2396-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2397-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2398-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2399-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2400-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2401-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2402-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2403-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2404-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2405-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2406-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2407-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2408-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2409-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2410-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2411-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2412-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2413-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2414-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2415-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2416-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2417-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2418-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2419-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2420-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2421-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2422-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2423-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2424-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2425-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2426-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2427-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2428-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2429-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2430-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2431-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2432-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2433-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2434-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2435-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2436-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2437-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2438-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2439-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2440-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2441-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2442-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2443-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2444-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2445-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2446-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2447-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2448-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2449-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2450-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2451-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2452-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2453-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2454-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2455-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2456-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2457-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2458-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2459-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2460-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2461-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2462-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2463-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2464-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2465-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2466-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2467-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2468-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2469-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2470-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2471-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2472-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2473-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2474-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2475-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2476-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2477-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2478-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2479-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2480-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2481-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2482-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2483-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2484-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2485-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2486-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2487-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2488-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2489-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2490-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2491-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2492-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2493-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2494-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2495-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2496-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2497-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2498-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2499-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2500-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2501-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2502-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2503-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2504-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2505-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2506-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2507-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2508-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2509-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2510-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2511-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2512-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2513-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2514-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2515-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2516-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2517-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2518-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2519-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2520-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2521-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2522-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2523-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2524-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2525-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2526-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2527-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.