Reported Mar 11, 2020 · Terminated
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
Elecsys CA 19-9Cat. No. 07027028190 -
- Product Usagethe product is an immunoassay for monitoring and management of pancreatic cancer
- Lot codes and dates
- Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released
- lots are subject to the same workaround
4644950474525510and 568976
- Amount recalled
- 684
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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