Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
FDA Recall Z-1444-2020 · Posted 2020-03-05
Advertisement
Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeNIG
Date Initiated2020-02-07
Date Terminated2024-05-30
Product Quantity684
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.
Firm 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 10/5/20***
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement