Z-1249-2021 Class II Terminated
FDA device recall Z-1249-2021 was initiated by Medline Industries Inc on January 25, 2021 and is designated Class II. Reason for recall: Product was compromised during shipment. The recall status is terminated (terminated January 9, 2023). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- January 25, 2021
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product 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 for Recall
Product was compromised during shipment.
Distribution Pattern
US Nationwide distribution in the states of KY, PA, OH.
Code Information
lot number 072564