Z-2353-2017Class II
VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton
bioMerieux, Inc. / initiated 2017-04-20 / Terminated / root cause: packaging
Biomerieux Inc began a recall of VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 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-2353-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- bioMerieux, Inc.
- Product
- VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
- Product code
- LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- 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
- 75,502 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
- 1320165103 10/May/18 1320172103 17/May/18 1320172203 17/May/18 1320179203 24/May/18 1320186103 31/May/18 1320193103 07/Jun/18 1320194103 08/Jun/18 1320215103 29/Jun/18 1320215203 29/Jun/18 1320222103 06/Jul/18 1320223103 07/Jul/18 1320242103 26/Jul/18 1320242203 26/Jul/18 1320249103 02/Aug/18 1320250103 03/Aug/18 1320256103 09/Aug/18 1320256203 09/Aug/18 1320257103 10/Aug/18 1320263103 16/Aug/18 1320264103 17/Aug/18 1320264203 17/Aug/18 1320277103 30/Aug/18 1320277203 30/Aug/18 1320284103 06/Sep/18 1320284203 06/Sep/18 1320285103 07/Sep/18 1320285203 07/Sep/18 1320291103 13/Sep/18 1320291203 13/Sep/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.