Z-0522-2013 Class II Terminated
FDA device recall Z-0522-2013 was initiated by Roche Diagnostics Operations, Inc. on Nov 14, 2012 and is designated Class II. 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… The recall status is terminated (terminated Aug 7, 2013). Affected quantity: 23 units of Fluid Pack COOX, 200 were distributed.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2012
- Initiation Date
- Nov 14, 2012
- Termination Date
- Aug 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units of Fluid Pack COOX, 200 were distributed
Product Description
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.
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 Pattern
Nationwide Distribution including NE and AZ.
Code Information
Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0522-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026