Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports
Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.
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 reported injuries, which aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas p 512 Pre-Analytical Instrument, specifically the calculator/data processing module used in clinical diagnostic laboratories. The recall is due to four reported injuries 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. Users of the cobas 6800/8800 systems should contact Roche for further instructions on how to proceed with the recall and revised cleaning procedures.
The recalled product
- Product
- cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in…
- 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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