Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 501 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 meets the rubric criteria for a Severe (4) rating.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas p 501 Post-Analytical Unit calculator/data processing module. The recall is due to a sharp edge on the center guide rail of the analyzer's sample rack tray, which has caused four reported injuries.
The affected product is used in the MODULAR PRE-ANALYTICS system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling. The units were distributed nationwide in the United States.
Roche has revised the cleaning procedure for the sample rack tray to clarify the cleaning process. Users of this equipment should stop using the affected units and contact Roche for further instructions.
The recalled product
- Product
- cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR…
- 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.
See all 17 products in this recall →Related recalls
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