Recall Z-0769-2021— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2020-12-10, terminated 2023-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049. Reason: The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-10
- Terminated
- 2023-07-06
- Firm location
- Lenexa, KS, United States
Product description
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Reason for recall
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.