Microalbumin Reagent — Class II medical device recall Z-2124-2017
Terminated recall by Beckman Coulter Inc., reported 2017-05-31, distributed nationwide. Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published
| Recall number | Z-2124-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-04-24 |
| Classified | 2017-05-22 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, CA, CH, CN, CO, CZ, DE, ES, FR, GB, GT, IN, IT, JP, MX, NL, OM, PH, PT, QA, SA, TW, ZA |
| Model numbers | 475100 |
Product
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
Reason for recall
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
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-2124-2017. 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.