Cobas¿ infinity central lab IT solution Material Number: 07154003001… — Class II medical device recall Z-1368-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-05-29, distributed in AL, AZ, CA, GA, IA, MO, NJ, NY…. Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the res
| Recall number | Z-1368-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2019-02-04 |
| Classified | 2019-05-17 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-09-16 |
| Distributed | AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN, TX |
| Quantity | 15 units |
| Reason classes | software |
| Serial numbers | 81191, 81371, 81385, 81465, 81469, 81470, 81481, 81485, 81527, 81528, 81618, 81628, 81652, 81655, 81662 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1368-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.