FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: API 50 CH, Model 50300
- Recall number
- Z-0243-2022
- Recalling firm
- bioMerieux, Inc.
- Product
- API 50 CH, Model 50300
- Status
- Terminated
- Initiated
- 2021-09-30
- Posted
- not on file
- Terminated
- 2024-01-18
- Reason
- There is potential to provide an incorrect organism identification.
- Root cause
- Material/Component Contamination
- Action
- Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021. Customers are asked to do the following: -Discontinue use of and discard any remaining inventory of lot 1008679230. -For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we are asking you to identify any possible incorrect identification test result due to a false positive reaction of test 34, analyze the related risks and to determine appropriate actions, if relevant. -Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. -Distribute this information to all appropriate personnel in the laboratory, retain a copy in your files. -Contact your local bioMrieux representative for product compensation. Consignees will perform destruction activities at their site.
- Quantity
- 1382 kits
- Distribution
- Distribution in WI, NY, and SD
- Lot, serial or model codes
- Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSC
- 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