Roche cobas p 612 pre-analytical system recall: Contamination
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system…
Why was Roche cobas p 612 pre-analytical system recalled?
Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
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?
All units
- Product
- Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 12 units
- Distribution
- US Distribution to states of: CA, NY,TX, WA, and WI.
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)