Recall Z-3023-2011 ยท CGI Radioimmunoassay, Estriol
Beckman Coulter Inc.
Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
| Date | Aug 15, 2011 (initiated Dec 8, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release. |
| Root cause | Other |
| Action | Beckman Coulter sent a PRODUCT CORRECTIVE ACTION (PCA) letter dated December 8, 2009, to all affected customers. The letter was sent via US Postal Service for all US customers with attached PCA response form. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of Access Unconjugated Estriol reagent lot number 913348. " No further orders of Access Unconjugated Estriol reagent lot number 913348 will be shipped. " Abnormally low Access Unconjugated Estriol results from samples tested previously with |
| Quantity | 2786 units total (2776 in the US) |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.