VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 recallZ-0425-2022 · bioMerieux, Inc. · initiated Sep 22, 2021
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
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDA root cause category: Nonconforming Material/Component
What the company is doing
For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to [email protected] or Fax to: (919) 620-3306 to confirm receipt of this notice.
Recall details
- Recall number
- Z-0425-2022
- Status
- Open, Classified
- Initiated by the company
- Sep 22, 2021
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 50
- Product code
- LLH
- Distribution
- US Nationwide distribution.
Product description
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
Code information (models, lots, serial numbers)
UDI 03573026229146, Lot #s: 1008730880
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VIDAS® C. difficile Toxin A & B 30118-01Biomerieux SA · REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88797).
- Z-0426-2022 · Open, ClassifiedVIDAS Clostridium Difficile GDH, REF 30125-01
- Z-0427-2022 · Open, ClassifiedVIDAS DEX@, Dimer Exclusion II, REF 30455-01
- Z-0428-2022 · Open, ClassifiedVIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
- Z-0429-2022 · Open, ClassifiedVIDAS Mumps IgG (MPG), REF 30218
- Z-0430-2022 · Open, ClassifiedVIDAS Measles IgG (MSG), REF 30219
- Z-0431-2022 · Open, ClassifiedVIDAS TOXO IgG Avidity (TXGA), REF 30222-01
- Z-0432-2022 · Open, ClassifiedVIDAS RUB IgG (RBG), REF 30226
- Z-0433-2022 · Open, ClassifiedVIDAS LH, REF 30406-01
- Z-0434-2022 · Open, ClassifiedVIDAS FSH, REF 30407-01
- Z-0435-2022 · Open, ClassifiedVIDAS Estradiol II, REF 30431-01
- Z-0436-2022 · Open, ClassifiedVIDAS Lyme IgM II (LYM), REF 416436
- Z-0437-2022 · Open, ClassifiedVIDAS Lyme IgG II (LYM), REF 417401
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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