Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled full...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2944-2018.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2944-2018.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2944-2018.
Roche Diagnostics Corporation
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Roche Diagnostics Corporation Recall FAQ
Roche Diagnostics Corporation is the subject of a medical devices safety report: Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled full.... The notice was published on July 16, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 12 units are potentially affected.