Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with four reported injuries, meeting the rubric criteria for 'Severe' (Class II with injury reports).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 cobas p 471 centrifuge units, specifically the calculator/data processing module, for clinical use. 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 has 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 units were distributed nationwide in the United States.
Healthcare facilities and users of these devices should stop using the affected sample rack trays and follow the revised cleaning procedures provided by the manufacturer. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
- 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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