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…
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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026