Roche Recalls COBAS AmpliPrep Sample Tube Input Barcode Clips
Roche Molecular Systems is recalling certain lots of COBAS AmpliPrep barcode clips because they can cause sample tubes to stick, leading to aborted instrument runs.
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. The hazard involves an operational failure (aborted runs) rather than a direct safety risk to patients or erroneous results, fitting the criteria for a moderate severity issue.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 2,132 boxes of COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. The affected lots are 11049503, 11053503, 11054503, 11525503, and 11526503. These products were distributed nationwide in the United States.
The recall was initiated because the barcode clips can cause sample input tubes to stick. When this occurs, the COBAS AmpliPrep instrument lifts both the sample input tube and the barcode clip from the sample rack, resulting in an aborted run. The source text notes that no erroneous results would be produced if the issue occurs.
Users of the COBAS AmpliPrep Instrument should check their inventory for the specific catalog and lot numbers listed above. If the affected products are found, they should stop using them and contact Roche Molecular Systems for instructions on return or replacement.
The recalled product
- Product
- COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 2,132
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 (4)
- Lot Numbers: 11049503
- 11053503
- 11054503
- 11525503 and 11526503.
Distribution
Distributed nationwide across the United States.
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