cobas p 512 Pre-Analytical Instrument calculator/data recall
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an…
Why was cobas p 512 Pre-Analytical Instrument calculator/data recalled?
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Not applicable
- Product
- cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 9014 in total
- Distribution
- US Nationwide Distribution
- Recall date
- November 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)