Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury
Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail 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, meeting the rubric criteria for a Severe severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas p 612 Pre-Analytical Instrument calculator/data processing module. The recall is due to four reports of injury caused by the sharp edge of the center guide rail on the analyzers' sample rack tray.
The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations. 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. Healthcare facilities and users should contact Roche Diagnostics Operations, Inc. for further instructions on the recall and corrective actions.
The recalled product
- Product
- cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative…
- 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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