Recall Z-1249-2021 ยท JPK Mixture, Hematology Quality Control
Medline Industries Inc
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.
| Date | Jan 25, 2021 |
| Status | Terminated |
| Reason | Product was compromised during shipment. |
| Root cause | Process control |
| Action | The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of KY, PA, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853776 | MSI-HB HEMOGLOBIN CONTROL Medical Specialties, Inc., Sep 19, 1985 |