—#189571

Product

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

FDA product code: LLH — Reagents, Clostridium Difficile Toxin
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: UDI 03573026229146, Lot #s: 1008730880

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 USFieldActions@biomerieux.com or Fax to: (919) 620-3306 to confirm receipt of this notice.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.