Z-0321-2021Class II

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Name: Z-0321-2021 Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Creator: Primus Corporation
Published: 2020-10-09
License: https://open.fda.gov/license/

Trinity Biotech (Primus Corporation dba Trinity Biotech) / initiated 2020-10-09 / Terminated

FDA source

Primus Corporation began a recall of Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation on 2020-10-09. FDA classified it as Class II and gives the reason as "The product did not receive pre-market approval or clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0321-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-09
Posted: 2020-10-31
Terminated: 2021-11-04
Recalling firm: Trinity Biotech (Primus Corporation dba Trinity Biotech)
Product: Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Product code: GKA Abnormal Hemoglobin Quantitation
Reason for recall: The product did not receive pre-market approval or clearance.
FDA 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 in commerce: 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, Vietnam
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0321-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0321-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-10-31

Product code GKA

K955283Class IIPrimus Variant System Pvs99Primus Corp. / cleared 1996-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)