CLASS III Device recall · Reported 10 Jul 2019 · FDA Enforcement Report

cobas p 701 post-analytical units recalled by Roche Diagnostics

Roche Diagnostics is recalling cobas p 701 post-analytical units, distributed nationwide in the US. The recall was initiated on 4 Apr 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial Numbers - 1001 through 1037, and 502
Quantity recalled9 units

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-1928-2019
FDA event ID
82651
Recalling firm
Roche Diagnostics, Indianapolis, IN
Classification
Class III
Status
Terminated
Recall initiated
4 Apr 2019
FDA classified
2 Jul 2019
Reported
10 Jul 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

4 Apr 2019Recall initiated by company
2 Jul 2019Classified by FDA+89 days
10 Jul 2019Published 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

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

Product as listed by the FDA

cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

Where it was distributed

US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

Nationwide AlabamaCaliforniaFloridaIowaIllinoisKentuckyMarylandOregonPennsylvania

Questions about this recall

Is cobas p 701 post-analytical units recalled?

Yes. Roche Diagnostics recalled cobas p 701 post-analytical units on 4 Apr 2019. The recall is Class III and its status is Terminated. Recall number Z-1928-2019.

Why was it recalled?

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

Which lots are affected?

Serial Numbers - 1001 through 1037, and 502

Where was it sold?

US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 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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