Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.
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 Severe (Score 4) because the source text explicitly reports four injuries caused by the product defect, meeting the rubric criteria for significant injury reports.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas 6800/8800 system, which is used for Hepatitis Viral B DNA Detection. The recall is due to a safety hazard involving the sharp edge of the center guide rail on the analyzer's sample rack tray.
The company received four reports of injury caused by this sharp edge. To address the issue, the cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. The affected products were distributed nationwide in the United States.
Healthcare facilities and users of these systems should stop using the affected sample rack trays and follow the revised cleaning procedures provided by the manufacturer to prevent further injuries.
The recalled product
- Product
- cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping
- 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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