Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
This recall has been terminated (originally issued March 5, 2020).
- Recall Initiated
- February 7, 2020
- Posted
- March 5, 2020
- Terminated
- May 30, 2024
- Recall Number
- Z-1444-2020
- Quantity
- 684
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976
Root Cause
Nonconforming Material/Component
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.