Recall Z-2637-2017 ยท CEC Radioimmunoassay, Free Thyroxine
Beckman Coulter Inc.
Access System-Free T4 Assay, B01902E, Catalog No. 33880
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | The Access immunoassays are susceptible to biotin interference. |
| Root cause | Device Design |
| Action | An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy |
| Quantity | 1,154,084 units total (167,035 units in US) |
| Distribution | Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Ger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc., Jul 14, 1998 |