Roche cobas b 221 AutoQC Module Recall for Software Failure
Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.
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, and the defect is a software failure that prevents quality control checks from running. There are no reported injuries or illnesses, and the hazard is related to the integrity of the testing process rather than direct physical harm.
Plain-English summary
Roche Diagnostics Corporation is recalling 1,026 units of the cobas b 221 AutoQC Module Complete. The affected products are identified by catalog numbers 3313522001 and 3313522692. These modules are used with the Roche Diagnostics Omni S Analyzer, a fully automated critical care analyzer intended for measuring various blood and fluid parameters.
The recall is due to a software defect in the scheduler responsible for starting scheduled AutoQC measurements. The software will not activate, meaning the automated quality control checks do not run as intended. This issue could affect the reliability of the quality control process for the analyzer.
The products were distributed nationwide in the United States. Users of the affected modules should contact Roche Diagnostics for further instructions on how to resolve the software issue or obtain a replacement.
The recalled product
- Product
- cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit…
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 1,026
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 numbers: 3313522001 and 3313522692
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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