Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement o
FDA device recall Z-1077-2017 · posted 2017-01-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.
- Action taken
- Roche issued an Analyzer Bulletin on September 3, 2015, to all affected Consignees. The recall notifications included a description of the reason for the recall, affected product, and consignee responsibilities; the notification did not include instructions for responding to the notification. Actions Required " Follow the workaround outlined in this Analyzer Bulletin to avoid the described issue. " File this Analyzer Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions about the information contained in this Analyzer Bulletin.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 30
- Distribution
- Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
- Date initiated
- 2015-09-03
- Date posted
- 2017-01-23
- Date terminated
- 2017-06-05
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) | Roche Diagnostics | 2012-05-14 |