Device product
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.
Z-1249-2021
Product summary
- Event
- Event 87232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1249-2021
Official wording
Reason: Product was compromised during shipment.
Code information: lot number 072564
Distribution pattern: US Nationwide distribution in the states of KY, PA, OH.
Derived failure modes
-
Unknown
Product was compromised during shipment.