Roche VS II Aliquoter System recalled due to sharp edge injury risk
Roche is recalling VS II Aliquoter System calculator modules because a sharp edge on the sample rack tray caused four reported injuries.
What this means for you
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 involves a risk-of-harm product where injury has been reported (four cases), but the source does not indicate hospitalization or FDA Class I classification, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the VS II Aliquoter System calculator/data processing module used with the Elecsys 411 analyzer. The recall involves 9,014 units distributed nationwide in the United States.
The recall was initiated after Roche received four reports of injury caused by the sharp edge of the center guide rail on the analyzer's sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Healthcare facilities and users of the VS II Aliquoter System should contact Roche Diagnostics for instructions on how to proceed with the recall and the revised cleaning procedures.
The recalled product
- Product
- VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 9,014
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.
Part of a larger recall action
This product is one of 17 recalled by Roche Diagnostics Operations, Inc. 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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