Recall Z-0572-2013
Beckman Coulter Inc. · initiated November 5, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
Codes / lots: Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872
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
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0572-2013
- Initiated
- November 5, 2012
- Posted by FDA
- December 20, 2012
- Terminated
- May 14, 2014
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Quantity
- 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, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India…
- Recalling firm
- Beckman Coulter Inc., Brea, CA