Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports
Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries, which meets the criteria for a Severe rating (Score 4) under the rubric.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the RSD 800 Sorting System calculator/data processing module, used in the cobas 8000 Modular Analyze Series for clinical chemistry analysis. The recall was initiated after the company received four reports of injury caused by the sharp edge of the center guide rail of an analyzer's sample rack tray.
The affected modules were distributed nationwide in the United States. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. Users of these systems should contact Roche Diagnostics for further instructions on how to proceed with the recall and the updated cleaning procedures.
The recalled product
- Product
- RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in bo
- 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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