Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk
Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.
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 hazard is a potential for false positive results due to contamination rather than a direct physical injury or acute health threat, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Corporation is recalling 12 units of the cobas p 612 pre-analytical system (63x), Model 07563116001. The affected units were distributed in the United States to California, New York, Texas, Washington, and Wisconsin. The cobas p 612 is a computer-controlled, fully automatic system used for sorting sample tubes in clinical laboratories.
The recall is due to a risk that sample material may come into contact with the pipetting nozzle during operation when non-filter tips are used. The presence of biological material on the nozzle may cause contamination, which could result in potential false positive test results depending on the sensitivity of the analytical technology.
No specific instructions for consumers are provided in the source text, as this is a medical device used in professional laboratory settings. Healthcare facilities and laboratories should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for…
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 12
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)
- All units
Distribution
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