FDA Medical Device Recalls (openFDA)
Remel Inc: Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
- Recall number
- Z-0769-2021
- Recalling firm
- Remel Inc
- Product
- Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
- Status
- Terminated
- Initiated
- 2020-12-10
- Posted
- not on file
- Terminated
- 2023-07-06
- Reason
- The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
- Root cause
- Mixed-up of materials/components
- Action
- The recalling firm issued a recall notification letter dated 12/16/2020 to all impacted customers. The letter states that all impacted product has since expired on 12/10/2020. Customers are asked to review of reported test results should be determined by the appropriate technical expert. Customers are also asked to keep the notification letter on file. The notice should be passed on to all who need to be aware within the organization or to any organization where the potentially affected products have been transferred. Questions may be directed to the Technical Services Department at 1-800-255-6730 (US) or via email: microbiology.ts.us@thermofisher.com.
- Quantity
- 637 units
- Distribution
- Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
- Lot, serial or model codes
- Lot 150237
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSI
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- 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