Recall Z-3006-2020 ยท CGI Radioimmunoassay, Estriol
Beckman Coulter Inc.
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
| Date | Aug 26, 2020 |
| Status | Terminated |
| Reason | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| Root cause | Under Investigation by firm |
| Action | On 08/31/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via email and US Post informing them of the potential for an interference with bovine alkaline phosphatase (ALP) in a subset of patient samples tested with the Access Unconjugated Estriol (uE3) assay. Customers are instructed to: - Consider the patients total clinical presentation when interpreting results. - Any retrospective review of patient results is left to the discretion of the Medical Director. - Contact Beckman Coulter Technical Support if you suspect ALP associated interference and do not report |
| Quantity | 21455 assay systems |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.