Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 18, 2023
cobas infinity central lab, Material Number 07154003001
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 recei…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diagnostics Operations, Inc. recalled cobas infinity central lab, Material Number 07154003001 - a moderate-severity action.
cobas infinity central lab, Material Number 07154003001 was recalled by Roche Diagnostics Operations, Inc. in January 18, 2023. Reason: A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability …. Check the official notice for the remedy. Verify recall #Z-0952-2023 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability ….
- Moderate
- severity level
- Class II
- classification
- January 18, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0952-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0952-2023) was formally reported on January 18, 2023, with the manufacturer initiating the action on December 12, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 224 US; 2,797 worldwide.
The documented reason for this recall is: 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 Syst… Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution pending.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
224 US; 2,797 worldwide
Related Recalls
6
3 from same agency
Product description
cobas infinity central lab, Material Number 07154003001
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0952-2023 |
| Date reported | January 18, 2023 |
| Date initiated | December 12, 2022 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 224 US; 2,797 worldwide |
| Distribution | Domestic distribution nationwide. Foreign distribution pending. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0952-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
cobas infinity central lab, Material Number 07154003001. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 224 US; 2,797 worldwide.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0952-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution nationwide. Foreign distribution pending..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0952-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 18, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.