Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports
Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers 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 aligns with the 'Severe' criteria for significant injury reports or Class II recalls with adverse events.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas 8000 Modular Analyzer Series c8000 and the Modular e602 Immunoassay Analyzer. These devices are used for clinical chemistry and immunoassay testing. The recall is due to four reports of injury caused by the sharp edge of the center guide rail on the analyzer's sample rack tray.
The affected units were distributed nationwide in the United States. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. The source text does not specify the exact nature of the injuries or the dates of the incidents.
Healthcare facilities and users of these devices should stop using the affected sample rack trays and contact Roche Diagnostics for further instructions on the revised cleaning procedure and any necessary corrective actions.
The recalled product
- Product
- cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcod
- 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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