FDA Device recall Z-0016-2013
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA by Beckman Coulter, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0016-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-01-20 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | CA, CT, OH |
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
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%.
Identifiers
| code_info | Lot # 110919D, 111017C, 111017D, 111114C, 111212C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2013%22
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