Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk
Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail 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 FDA Class II, and the source text explicitly reports four injuries, which aligns with the rubric criteria for a Severe rating involving significant injury reports.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas 6000 Series system c6000 and Modular e601 Immunoassay Analyzer. The recall was initiated after the company received four reports of injury caused by the sharp edge of the center guide rail on the analyzer's sample rack tray.
The affected products are intended for clinical use and were distributed nationwide in the United States. The sample rack tray is used to store primary and secondary sample tubes in a controlled, refrigerated environment.
To address the issue, Roche has revised the cleaning procedure for the sample rack tray to clarify the cleaning process. Users of these devices should consult the updated instructions provided by the manufacturer.
The recalled product
- Product
- cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. A
- 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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