Recall Z-1368-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
| Date | Feb 4, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Roche Diagnostics issued on 2/04/19 an "URGENT MEDICAL DEVICE CORRECTION"(UMDC) letter to its customers via UPS Ground (receipt required). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: " When using the automated bottle change function, ensure Good Laboratory Practices (GLP) are being followed (i.e., all QC results for the current and standby bottles are in range and are not flagged prior to testing patient samples). " Complete the attached fax form (TP-00548) and fax this form to 1-866-608-3939 or email it to Roche10042@ |
| Quantity | 15 units |
| Distribution | US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.