Roche Recalls Elecsys CA 19-9 Reagent Due to Non-Reproducible Results
Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where non-reproducible results may affect clinical interpretation, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 684 units of Elecsys CA 19-9 reagent, Catalog Number 07027028190. This product is an immunoassay used for the monitoring and management of pancreatic cancer.
The recall was initiated after the firm received an increased number of complaints regarding non-reproducible elevated results, referred to as "high flyers," for one lot of the reagent. These results may affect clinical interpretation.
The affected product was distributed nationwide 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. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- Product
- Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 684
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 50474
- 525510
- and 568976
Distribution
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