Z-2447-2015 Class II Terminated
FDA device recall Z-2447-2015 was initiated by Roche Diagnostics Operations, Inc. on Jul 14, 2015 and is designated Class II. Reason for recall: Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be… The recall status is terminated (terminated Jan 19, 2016). Affected quantity: 82 Fluid Packs.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2015
- Initiation Date
- Jul 14, 2015
- Termination Date
- Jan 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82 Fluid Packs
Product Description
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
Reason for Recall
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
Distribution Pattern
US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
Code Information
cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2447-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026