Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
This recall has been terminated (originally issued February 4, 2019).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- February 4, 2019
- Terminated
- September 16, 2020
- Recall Number
- Z-1368-2019
- Quantity
- 15 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
Lot / Code Info
Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662
Root Cause
Software design
Action Taken
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@stericycle.com. " When a new software version is available, a Roche representative will contact you to schedule the software update. " File this UMDC for future reference. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions