FDA Device recall Z-0321-2021
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation by Primus, citing the product did not receive pre-market approval or clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0321-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-09 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Primus |
| Distribution | AZ, CA, DC, FL, GA, IL, LA, MA, MI, MO, NE, NJ, NV, NY, PA, RI, TN, TX, VA, WI |
Product
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Reason
The product did not receive pre-market approval or clearance.
Identifiers
| code_info | Product Name and Product Code ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column…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 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0321-2021%22
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