Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 701 Post-Analytical 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 is classified as FDA Class II and involves four reported injuries, which aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 cobas p 701 Post-Analytical Units, which are calculator/data processing modules intended for clinical use with the URISYS 2400 Analyzer. The recall is due to a sharp edge on the center guide rail of the analyzer's sample rack tray.
The company received four reports of injury caused by this sharp edge. 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 professionals should stop using the affected units and contact Roche Diagnostics Operations, Inc. for further instructions on the recall and revised cleaning procedures.
The recalled product
- Product
- cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH…
- 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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