FDA Medical Device Recalls (openFDA)
Biomerieux Inc: PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
- Recall number
- Z-0793-2023
- Recalling firm
- Biomerieux Inc
- Product
- PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
- Status
- Open, Classified
- Initiated
- 2022-11-09
- Posted
- 2023-01-04
- Terminated
- not on file
- Reason
- As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Root cause
- Storage
- Action
- Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.
- Quantity
- 10 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 03573026263140, Batch Numbers: 230438
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JST
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- 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