Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
This recall has been terminated (originally issued December 13, 2012).
- Recall Initiated
- November 14, 2012
- Posted
- December 13, 2012
- Terminated
- August 7, 2013
- Recall Number
- Z-0522-2013
- Quantity
- 23 units of Fluid Pack COOX, 200 were distributed
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
Distribution
Nationwide Distribution including NE and AZ.
Lot / Code Info
Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
Root Cause
Software design (manufacturing process)
Action Taken
Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272. For questions regarding this recall call 317-521-3966.