Z-1368-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
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.
Distribution Pattern
US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
Code Information
Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662