Roche cobas c 503 Analyzer Recalled for Inaccurate Test Results
Roche Diagnostics is recalling cobas c 503 analyzers and kits because residual reagent transfer can cause inaccurately low results for therapeutic drug monitoring tests.
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 is classified as FDA Class II and involves a risk of harm (inaccurate test results) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 152 kits and 7 units of the cobas pro integrated solutions -cobas c 503 Analyzer, a chemistry analyzer used for clinical purposes. The recall is due to a defect where residual reagent can sporadically transfer from the conus into the reaction cuvette during the first or second measurement pipetting. This transfer can lead to inaccurately low results for affected Therapeutic Drug Monitoring (TDM) tests.
The affected products were distributed domestically in Illinois, Florida, Georgia, and West Virginia. The recall involves specific catalog numbers: 08445605190, 08445567190, 08253153190, and 08058580190. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users of the cobas c 503 Analyzer should stop using the affected units and kits and contact Roche Diagnostics for instructions on returning the products or obtaining replacements. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
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 (1)
- Catalog Number 08445605190 08445567190 08253153190 08058580190
Distribution
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