FDA Recall
Terminated
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
Recall: Z-1249-2021
·
Initiated January 25, 2021
Recall
- Recall Number
- Z-1249-2021
- Event Number
- 87232
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- JPK
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 25, 2021
- Terminated
- January 9, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
Reason
Product was compromised during shipment.
Action
The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.
Distribution
US Nationwide distribution in the states of KY, PA, OH.
Quantity
4 units