Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2019
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when usi…
Roche Diagnostics Corporation recalled Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Dat… - a moderate-severity action.
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Dat… was recalled by Roche Diagnostics Corporation in May 29, 2019. Reason: Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the re…. Check the official notice for the remedy. Verify recall #Z-1368-2019 with the FDA Devices before acting.
The recall
Roche Diagnostics Corporation issued this moderate-severity FDA Devices recall-Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the re….
- Moderate
- severity level
- 15 units
- affected scope
- Class II
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1368-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1368-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on February 4, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Corporation is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 15 units.
The documented reason for this recall is: Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does no… Distribution data in the federal record shows the product reached: US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.. 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, 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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.
Affected scope
15 units
Related Recalls
6
6 from same agency
Product description
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Reason for recall
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1368-2019 |
| Date reported | May 29, 2019 |
| Date initiated | February 4, 2019 |
| Recalling firm | Roche Diagnostics Corporation |
| Firm location | Indianapolis, IN |
| Affected scope | 15 units |
| Distribution | US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX. |
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-1368-2019) 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 IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use. Recalled by Roche Diagnostics Corporation. Units affected: 15 units.
Why was this product recalled? ▼
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1368-2019.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1368-2019) 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.
Nearby Recalls in This Category
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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 May 29, 2019. 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 August 2026.