Recall Z-2638-2017 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Beckman Coulter Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
| 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 | 249,597 units total (9,388 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
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 Beckman Coulter, Inc., Dec 29, 2003 |