Recall Z-1736-2011 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Beckman Coulter Inc.
Access Total BhCG (BhCG) Assay Part Number 33500 The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
| Date | Mar 21, 2011 (initiated Oct 20, 2010) |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. The role of preanalytical factors in laboratory testing has been described in a variety of published literature. |
| Root cause | Pending |
| Action | Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:. " Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results. " Follow the sample handling instructions provided in the Access Total hCG Instruction for Use (IFU). " Review the enclosed pre-analytical sample handling information bulletins: 1. The Role of Preanalytical F |
| Quantity | 158,919 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Ge |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 Beckman Instruments, Inc., Mar 18, 1998 |