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Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

FDA Device Recall #Z-0321-2021 — Class II — October 9, 2020

Recall Summary

Recall Number Z-0321-2021
Classification Class II — Moderate risk
Date Initiated October 9, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Primus Corporation
Location Kansas City, MO
Product Type Devices
Quantity 97 devices (USA only)

Product Description

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Reason for Recall

The product did not receive pre-market approval or clearance.

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

Lot / Code Information

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

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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