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Roche Diagnostics Operations, Inc. recalls Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of p
Recalled December 19, 2012 · FDA recall Z-0522-2013 · Roche Diagnostics Operations
Hazard
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 · FDA Class II
Units
23 units of Fluid Pack COOX, 200 were distributed
Sold at
Nationwide Distribution including NE and AZ.
Description
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
Product
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →