Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas e411 Immunoassay 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 source text explicitly states that four reports of injury were received. According to the rubric, FDA Class II recalls with injury reports are classified as Severe (Score 4).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 cobas e411 Immunoassay Analyzers distributed nationwide in the United States. 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 product is a medical device intended for diagnostic use. The specific hazard involves the physical design of the sample rack tray, which poses a risk of laceration or cuts to users interacting with the equipment. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process, but the physical defect remains the primary reason for the recall.
Users of the cobas e411 Immunoassay Analyzer should contact Roche Diagnostics Operations, Inc. for instructions on how to proceed with the recall. The agency has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- cobas e411 Immunoassay Analyzer e411: 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. Automatic retrieval for add-on testing is possible at any time
- 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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