Class II — Roche Diagnostics Operations, Inc.
| Recalling firm | Roche Diagnostics Operations Inc. |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer |
| 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. |
| Initiated | 2020-02-07 |
| Classified | 2020-03-05 |
| Terminated | 2024-05-30 |
| Recall number | Z-1444-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Roche Diagnostics Operations, Inc. (Z-1444-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84915/
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