FDA Device recall Z-2447-2015
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 i…
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of 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 i… by Roche Diagnostics Operations, citing 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 Q….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2447-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-14 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
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
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
Identifiers
| code_info | cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2447-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.