The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of lute
FDA device recall Z-0572-2013 · posted 2012-12-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
- Action taken
- Beckman Coulter Inc. (BEC) sent an "URGENT FIELD SAFETY NOTICE" dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these the affected lots did not meet BEC's procedural requirements for a 12-month shelf-life claim. Contact the firm at 952-448-4848 for assistance with this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CEP
- Quantity affected
- 14409
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Chile, Ch
- Date initiated
- 2012-11-05
- Date posted
- 2012-12-20
- Date terminated
- 2014-05-14
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY (K940549) | Bio-Rad Laboratories, Inc. | 1994-04-06 |