Device product
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Z-0769-2021
Product summary
- Firm
- Remel Inc
- Event
- Event 87010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 637 units
- Official record key
device-enforcement:Z-0769-2021
Official wording
Reason: The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Code information: Lot 150237
Distribution pattern: Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
Derived failure modes
-
Unknown
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.