Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
This recall has been terminated (originally issued October 9, 2020).
- Company
- Primus Corporation
- Recall Initiated
- October 9, 2020
- Terminated
- November 4, 2021
- Recall Number
- Z-0321-2021
- Quantity
- 97 devices (USA only)
- Firm Location
- Kansas City, MO
- Official Source
- View on FDA website ↗
Reason for Recall
The product did not receive pre-market approval or clearance.
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, Vietnam
Lot / Code Info
Product Name and Product Code ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column / 01-05-0011 Resolution Analytical Column / 01-05-0015 FASC Position Marker / 01-04-0042 A2+F Control Material Kit / 01-04-0043 Mobile Phase 1 Reagent 3.8L / 01-03-0040 Mobile Phase 1 Reagent 940mL / 01-03-0042 Mobile Phase 2 Reagent 3.8L / 01-03-0041 Mobile Phase 2 Reagent 940mL / 01-03-0044 2 Diluent Reagent 3.8L / 01-03-0056 2 Diluent Reagent 940mL / 01-03-0059 System Wash Reagent / 01-03-0035 Analyzer Unit serial numbers: 100242 100314 100331 100354 100468 100541 100638 100746 100243 100316 100332 100355 100485 100551 100639 100747 100244 100317 100334 100356 100492 100558 100644 100751 100245 100319 100335 100357 100501 100559 100645 100758 100300 100321 100337 100358 100503 100561 100654 100765 100301 100322 100338 100359 100507 100562 100660 100802 100304 100323 100342 100360 100508 100563 100664 100305 100324 100343 100361 100510 100572 100666 100306 100325 100344 100404 100515 100574 100683 100309 100326 100345 100411 100518 100587 100729 100310 100327 100348 100416 100527 100590 100730 100312 100329 100351 100427 100531 100627 100743 100313 100330 100353 100446 100533 100633 100745
Root Cause
No Marketing Application
Action Taken
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.