Recall Z-0810-2023
Biomerieux Inc · initiated November 9, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
API JAMES 2AMP, CATALOG 70542
Codes / lots: UDI/DI 03573026099893, Batch Numbers: 1009360510
Reason for recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
FDA-determined cause: Storage
Action taken
Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.
Details
- Recall number
- Z-0810-2023
- Initiated
- November 9, 2022
- Posted by FDA
- January 4, 2023
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution.
- Recalling firm
- Biomerieux Inc, Hazelwood, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0783-2023 Class II | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0784-2023 Class II | API 20 E 25 STRIPS, CATALOG 20100As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0785-2023 Class II | API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0786-2023 Class II | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0787-2023 Class II | VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0788-2023 Class II | VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0789-2023 Class II | VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0790-2023 Class II | VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0791-2023 Class II | VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0792-2023 Class II | VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0793-2023 Class II | PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0794-2023 Class II | PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0795-2023 Class II | VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0796-2023 Class II | VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0797-2023 Class II | VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0798-2023 Class II | VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0799-2023 Class II | VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0800-2023 Class II | VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0801-2023 Class II | PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0802-2023 Class II | PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0803-2023 Class II | PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0804-2023 Class II | PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0805-2023 Class II | BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0806-2023 Class II | BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0807-2023 Class II | BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0808-2023 Class II | API VP1 VP2 REAGENTS, CATALOG 70422As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0809-2023 Class II | API NIT1 NIT2 REAGENTS, CATALOG 70442As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0811-2023 Class II | TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0812-2023 Class II | ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |
| Z-0813-2023 Class II | PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 11/09/2022Open, Classified |