Z-0769-2021 Class II Terminated
FDA device recall Z-0769-2021 was initiated by Remel Inc on December 10, 2020 and is designated Class II. Reason for recall: The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. The recall status is terminated (terminated July 6, 2023). Affected quantity: 637 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 10, 2020
- Termination Date
- July 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 637 units
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.
Distribution Pattern
Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
Code Information
Lot 150237