Unrated Medical device recall · FDA · Published October 9, 2020

Primus Ultra2 Resolution Variants System: Unapproved Medical Device Recall

Primus Corporation recalls specific Ultra2 Resolution Variants System models due to lack of pre-market approval. Affected units may pose health risks if used without regulatory clearance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0321-2021Medical device Primus ›

Recall notice

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

Take action

Contact the company

Recalling firmPrimus Corporation4231 E 75th Ter · Kansas City, MO 64132-2059

✎ GovInfoNow plain-language explainer

Primus Corporation is recalling certain Ultra2 Resolution Variants System models because they were not approved by regulators before being sold. Using these devices without proper clearance could lead to health risks. Read more at govinfonow.com/recall/64102-primus-ultra2-resolution-variants-system-unapproved-medical-device-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/64102-primus-ultra2-resolution-variants-system-unapproved-medical-device-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0321-2021

Cite this page

“Primus Ultra2 Resolution Variants System: Unapproved Medical Device Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64102-primus-ultra2-resolution-variants-system-unapproved-medical-device-recall. Based on FDA recall #Z-0321-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0321-2021%22&limit=1).

The Food and Drug Administration announced on Oct. 9, 2020, that Primus Corporation voluntarily recalled Ultra2 Resolution Variants Systems for Abnormal Hemoglobin Quantitation because the devices lacked pre-market approval or clearance. The recall affects 97 units distributed in the United States and several international markets.

How to tell if you have it

Brand: Primus
Product: Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
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
Product codes: 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
Quantity: 97 devices

The hazard

The recalled devices did not receive pre-market approval or clearance from the Food and Drug Administration, according to the agency. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show that Siemens CT Software Applications were recalled on Dec. 19, 2025, for being unapproved medical software. On the same date, Dec. 19, 2025, Siemens SOMATOM X.ceed Software Applications were also recalled for unapproved CT software. Other recent recalls of similar products include ReCor Paradise Ultrasound Renal Denervation System Recall (Jan. 29, 2026) for a nonconforming product hazard.

How to tell if you have this one

Check if your Ultra2 Resolution Variants System has the listed serial numbers in the recall notice. The affected units include specific analyzer units with serial numbers starting with 100242 through 100802.

Brand
Primus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Serial Numbers
Look for the serial numbers on the analyzer unit, which range from 100242 to 100802 as listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 19 states and D.C., and outside the U.S.

FDA 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 -…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Oct 9, 2020Firm started the recall
Oct 31, 2020FDA classified it Class II
Nov 11, 2020Published in FDA’s Enforcement Report
Nov 4, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64102-primus-ultra2-resolution-variants-system-unapproved-medical-device-recall">Primus Ultra2 Resolution Variants System: Unapproved Medical Device Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0321-2021 (October 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0321-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.