Recall Z-0050-2012 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Beckman Coulter Inc.
Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.
| Date | Oct 17, 2011 (initiated Mar 5, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision. |
| Root cause | Nonconforming Material/Component |
| Action | The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs. Customers were asked to review their historical records |
| Quantity | 14,764 |
| Distribution | Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023480 | ACCESS TOTAL BHCG Beckman Coulter, Inc., Dec 20, 2002 |