Recall Z-0321-2021 ยท GKA Abnormal Hemoglobin Quantitation
Primus Corporation
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
| Date | Oct 9, 2020 |
| Status | Terminated |
| Reason | The product did not receive pre-market approval or clearance. |
| Root cause | No Marketing Application |
| Action | Recall letters have been sent to US consignees via Federal Express Priority Overnight delivery. Customers were advised to transition to alternate testing methods and qualify a replacement device by March 7, 2021. During the transition, consumables will be made available for use but must be destroyed upon return of the analyzer. Customers were also instructed to agree to the above requirements and return a Fax Back Form confirming compliance. Follow-up will be conducted with consignees that do not reply to the recall notification. |
| Quantity | 97 devices (USA only) |
| Distribution | US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin OUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955283 | PRIMUS VARIANT SYSTEM PVS99 Primus Corp., Mar 1, 1996 |