Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides
FDA device recall Z-0016-2013 · posted 2012-10-05 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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%.
- Action taken
- Beckman Coulter sent an Urgent Production Correction letter dated January 10, 2012 to all their customers who purchased the Manual Immunoassay Active Renin IRMA Test Kit. The letter provides the customers with an explanation of the problem and actions to be taken. Customers were instructed to discontinue use and discard all remaining affected inventory. Customers were asked to complete and return the enclosed Response Form with in 10 days. Customers with questions contact Customer Service Support at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CIB
- Quantity affected
- 216 units total (6 units in the US)
- Distribution
- Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary
- Date initiated
- 2012-01-20
- Date posted
- 2012-10-05
- Date terminated
- 2012-10-05
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (K981607) | Diagnostic Systems Laboratories, Inc. | 1998-05-27 |