Roche recalls cobas p 612 pre-analytical systems (model 07563116001) due to potential contamination causing false positive test results. All units are affected.
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.
Roche is recalling its cobas p 612 pre-analytical systems (model 07563116001) because biological material on the pipetting nozzle could cause false positive test results. This affects laboratory equipment used for clinical testing.
The pipetting nozzle may come into contact with sample material during use, potentially contaminating the nozzle with biological material. This contamination could lead to false positive test results depending on the sensitivity of the analytical technology.
Laboratories using the cobas p 612 pre-analytical system (model 07563116001) are affected. Those performing clinical tests with this equipment are most at risk of false positive results.
Check for the model number 07563116001 on the cobas p 612 pre-analytical system. All units of this model are affected by the recall.
Look for the model number 07563116001 on the cobas p 612 pre-analytical system.
The model number is 07563116001.
The pipetting nozzle may come into contact with sample material, potentially causing contamination that could lead to false positive test results.
No specific action is required beyond checking the model number. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2944-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-2944-2018 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
