FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: VIDAS SARS-COV-2 IgG, Ref 423834-01
- Recall number
- Z-0439-2022
- Recalling firm
- bioMerieux, Inc.
- Product
- VIDAS SARS-COV-2 IgG, Ref 423834-01
- Status
- Open, Classified
- Initiated
- 2021-09-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- Two lots
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI 03573026620745, Lot #: 1008671430, 1008763910
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28