Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pa
FDA device recall Z-1444-2020 · posted 2020-03-05 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- 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.
- Action taken
- 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 10/5/20*** On 10/2/20, the firm issued an updated letter to customers to communicate an expansion to the recall. An additional lot was added to the recall scope.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NIG
- Quantity affected
- 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.
- Date initiated
- 2020-02-07
- Date posted
- 2020-03-05
- Date terminated
- 2024-05-30
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET (K050231) | Roche Diagnostics Corp. | 2005-07-06 |