Z-2372-2017Class II
VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton
bioMerieux, Inc. / initiated 2017-04-20 / Terminated / root cause: packaging
Biomerieux Inc began a recall of VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 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-2372-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- bioMerieux, Inc.
- Product
- VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 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
- 19,398 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
- 5400115203 21/Mar/18 5400122223 28/Mar/18 5400136203 11/Apr/18 5400136223 11/Apr/18 5400136243 11/Apr/18 5400143203 18/Apr/18 5400192203 06/Jun/18 5400192223 06/Jun/18 5400192243 06/Jun/18 5400199203 13/Jun/18 5400216203 30/Jun/18 5400221203 05/Jul/18 5400238203 22/Jul/18 5400238223 22/Jul/18 5400238243 22/Jul/18 5400262223 15/Aug/18 5400269203 22/Aug/18 5400276203 29/Aug/18 5400276213 29/Aug/18 5400283203 05/Sep/18 5400283213 05/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.