Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Recall Z-0321-2021 · Posted None
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Recalling FirmPrimus Corporation
Recall StatusTerminated
Product CodeGKA
Date Initiated2020-10-09
Date Terminated2021-11-04
Product Quantity97 devices (USA only)
Reason for Recall
The product did not receive pre-market approval or clearance.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
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, Vietnam
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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