CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

cobas infinity central lab, Material Number recalled

Roche Diagnostics Operations is recalling cobas infinity central lab, Material Number 07154003001, distributed nationwide in the US. The recall was initiated on 12 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codescobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted: 1. Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3. Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4. Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007

Quantity recalled224 US; 2,797 worldwide

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-0952-2023
FDA event ID: 91299
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2022
FDA classified: 12 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

12 Dec 2022	Recall initiated by company
12 Jan 2023	Classified by FDA	+31 days
18 Jan 2023	Published in enforcement report	+6 days

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

Reason for recall

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

cobas infinity central lab, Material Number 07154003001

Where it was distributed

Domestic distribution nationwide. Foreign distribution pending.

Nationwide

Questions about this recall

Is cobas infinity central lab, Material Number 07154003001 recalled?

Yes. Roche Diagnostics Operations recalled cobas infinity central lab, Material Number 07154003001 on 12 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0952-2023.

Why was it recalled?

Which lots are affected?

cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted: 1. Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3. Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4. Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007

Where was it sold?

Domestic distribution nationwide. Foreign distribution pending.

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 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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