Roche Cobas c502 Analyzer Recall Due to Inactive Volume Check
Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect in a safety check feature, which fits the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 76 units of the Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001. These are clinical chemistry analyzers intended for the in vitro quantitative and qualitative determination of analytes in body fluids. The units were distributed nationwide in the United States, including San Juan, Puerto Rico.
The recall is due to a defect where the Initial Cassette Volume Check (ICVC) is not activated on the cobas c502 module when manually filled cobas c packs are loaded. This issue specifically occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature is designed to allow the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles.
Healthcare facilities and laboratories that possess these specific units should contact Roche Diagnostics Operations, Inc. for instructions on how to resolve the issue. The source text does not provide specific contact details or a deadline for the recall.
The recalled product
- Product
- Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 76
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)
- not applicable
Distribution
Distributed nationwide across the United States.
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