Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation — Class II medical device recall Z-0321-2021
Terminated recall by Primus Corporation, reported 2020-11-11, distributed in AZ, CA, DC, FL, GA, IL, LA, MA…. The product did not receive pre-market approval or clearance.
| Recall number | Z-0321-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Primus Corporation, Kansas City, MO, United States |
| Recall initiated | 2020-10-09 |
| Classified | 2020-10-31 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-11-04 |
| Distributed | AZ, CA, DC, FL, GA, IL, LA, MA, MI, MO, NE, NJ, NV, NY, PA, RI, TN, TX, VA, WI |
| Countries outside the US | AE, BH, GB, IR, MY, SA, TR, TW, VN |
| Quantity | 97 devices |
| Serial numbers | 100242, 100243, 100244, 100245, 100300, 100301, 100304, 100305, 100306, 100309, 100310, 100312, 100313, 100314, 100316, 100317, 100319, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100329 and 72 more |
Product
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Reason for recall
The product did not receive pre-market approval or clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0321-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.