CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

cobas infinity core, Material No. recalled

Roche Diagnostics Operations is recalling cobas infinity core, Material No. 7154003001, distributed in 19 states. The recall was initiated on 7 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll cobas infinity laboratory solution software versions are affected.

Quantity recalled26 accounts

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-1158-2020
FDA event ID: 84697
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2020
FDA classified: 12 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Jan 2020	Recall initiated by company
12 Feb 2020	Classified by FDA	+36 days
19 Feb 2020	Published in enforcement report	+7 days

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

Reason for recall

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Where it was distributed

Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

Alaska Alabama California Georgia Hawaii Iowa Illinois Kentucky Massachusetts Michigan Minnesota Missouri Mississippi Montana New Jersey New York Oregon South Carolina Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

All cobas infinity laboratory solution software versions are affected.

Where was it sold?

Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

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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