Z-2378-2017Class II
VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton
bioMerieux, Inc. / initiated 2017-04-20 / Terminated / root cause: packaging
Biomerieux Inc began a recall of VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 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-2378-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- bioMerieux, Inc.
- Product
- VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
- Product code
- NGZ Susceptibility Test Plate, Antifungal
- 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
- 2251 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
- 2850108203 14/Mar/18 2850209403 23/Jun/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.