Vitek 2 Reagent Ast-Gp78 Test Kit 20 Cards, Catalog 421051 recallZ-0850-2023 · Biomerieux Inc · initiated Nov 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomerieux Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
FDA root cause category: Storage
What the company is doing
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.
Recall details
- Recall number
- Z-0850-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 9, 2022
- Posted by the FDA
- Jan 4, 2023
- Recalling firm
- Biomerieux Inc
- Quantity
- 26 units
- Product code
- LON
- Distribution
- US Nationwide distribution.
Product description
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Code information (models, lots, serial numbers)
UDI/DI 03573026553982, Batch Numbers: 2782225503
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITEK® 2 AST-GP78Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls41 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91148).
- Z-0783-2023 · Open, ClassifiedAPI LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
- Z-0784-2023 · Open, ClassifiedAPI 20 E 25 STRIPS, CATALOG 20100
- Z-0785-2023 · Open, ClassifiedAPI 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
- Z-0786-2023 · Open, ClassifiedAPI STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
- Z-0787-2023 · Open, ClassifiedVITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
- Z-0788-2023 · Open, ClassifiedVITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
- Z-0789-2023 · Open, ClassifiedVITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
- Z-0791-2023 · Open, ClassifiedVITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
- Z-0792-2023 · Open, ClassifiedVITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
- Z-0793-2023 · Open, ClassifiedPREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
- Z-0795-2023 · Open, ClassifiedVIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
- Z-0796-2023 · Open, ClassifiedVIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
- Z-0797-2023 · Open, ClassifiedVIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
- Z-0800-2023 · Open, ClassifiedVIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
- Z-0801-2023 · Open, ClassifiedPPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
- Z-0802-2023 · Open, ClassifiedPPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
- Z-0803-2023 · Open, ClassifiedPPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
- Z-0804-2023 · Open, ClassifiedPPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
- Z-0808-2023 · Open, ClassifiedAPI VP1 VP2 REAGENTS, CATALOG 70422
- Z-0809-2023 · Open, ClassifiedAPI NIT1 NIT2 REAGENTS, CATALOG 70442
- Z-0810-2023 · Open, ClassifiedAPI JAMES 2AMP, CATALOG 70542
- Z-0814-2023 · Open, ClassifiedVITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
- Z-0815-2023 · Open, ClassifiedVITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
- Z-0816-2023 · Open, ClassifiedVITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
- Z-0817-2023 · Open, ClassifiedETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
- Z-0818-2023 · Open, ClassifiedETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
- Z-0819-2023 · Open, ClassifiedETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
- Z-0820-2023 · Open, ClassifiedETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
- Z-0821-2023 · Open, ClassifiedETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
- Z-0822-2023 · Open, ClassifiedETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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