Active Renin IRMA Kit — Class II medical device recall Z-0016-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-17, distributed in CA, CT, OH. The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit
| Recall number | Z-0016-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-01-20 |
| Classified | 2012-10-05 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2012-10-05 |
| Distributed | CA, CT, OH |
| Countries outside the US | AR, AT, BE, BR, CA, CH, CN, CZ, DE, ES, FR, GB, GR, HU, IT, KW, NL, PL, PT, SK, TR |
| Reason classes | specification failure |
| Lot numbers | 110919D, 111017C, 111017D, 111114C, 111212C |
| Model numbers | DSL25100 |
Product
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%.
Machine access
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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.