CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

cobas p 612 pre-analytical system recalled by Roche Diagnostics

Roche Diagnostics is recalling cobas p 612 pre-analytical system, distributed in Texas, Washington. The recall was initiated on 27 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 63004316 63004416 63004516 63002816 63002916

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1090-2017
FDA event ID: 76078
Recalling firm: Roche Diagnostics, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 27 Dec 2016
FDA classified: 24 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Dec 2016	Recall initiated by company
24 Jan 2017	Classified by FDA	+28 days
1 Feb 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Not stated in the enforcement report.

Product as listed by the FDA

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

Where it was distributed

TX and WA

Texas Washington

Questions about this recall

Why was it recalled?

The reason has not been published.

Which lots are affected?

Serial Number 63004316 63004416 63004516 63002816 63002916

Where was it sold?

TX and WA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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