FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- Recall number
- Z-0742-2022
- Recalling firm
- bioMerieux, Inc.
- Product
- VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- Status
- Terminated
- Initiated
- 2022-02-09
- Posted
- 2022-03-14
- Terminated
- 2026-04-01
- Reason
- Invalid calibrations (out of range high) while using the product.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.
- Quantity
- 480 kits
- Distribution
- Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
- Lot, serial or model codes
- Lot numbers 1008873260, exp. 01JUN2022.
- 510(k) numbers
- ["K933549"]
- PMA numbers
- not on file
- Product code
- LKQ
- 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