Recall Z-1444-2020 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Roche Diagnostics Operations, Inc.
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
| Date | Mar 5, 2020 (initiated Feb 7, 2020) |
| Status | Terminated |
| Reason | The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation. |
| Root cause | Nonconforming Material/Component |
| Action | On February 7, 2020, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers were informed of the product issue and given two options for CA 19-9 testing until another reagent lot is available for the cobas e 801 module: 1) Use a different Roche platform for testing, or 2) Implement a workaround, described in detail in the customer letter. The letter also provided instructions for receiving credit depending on which option was elected. Roche will notify customers when a new lot of CA 19-9 reagent for the cobas e 801 is available for ordering. ***Updated 10 |
| Quantity | 684 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050231 | ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET Roche Diagnostics Corp., Jul 6, 2005 |