Z-1444-2020 Class II Terminated
FDA device recall Z-1444-2020 was initiated by Roche Diagnostics Operations, Inc. on February 7, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 30, 2024). Affected quantity: 684.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- February 7, 2020
- Termination Date
- May 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 684
Product Description
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
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 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.
Code Information
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