Recall Z-2446-2015
Roche Diagnostics Operations, Inc. · initiated July 14, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
cobas b 123 Fluid Pack COOX REF 05169992001 200 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.
Codes / lots: cobas b 123 Fluid Pack COOx Catalog 05169992001, lot numbers 21446113 (exp 8/8/2015), 21446123 (exp 8/18/2015), 21446153 ( exp 9/18/2015), 21446183 (exp 9/19/2015), and 21446203 (exp 10/01/2015)
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
FDA-determined cause: Nonconforming Material/Component
Action taken
Roche sent an Urgent Medical Device Correction letter dated July 14, 2015 and the Fax Back form via UPS ground to the customers list. The letter identified the affected product, problem and actions to be taken. Consignees are instructed to discontinue use of affected Fluid Packs and discard them per local guidlines; and complete and return the enclosed faxback form and fax it to 1-888-943-5171 to receive replacement product for Fluid Packs from the affected lot. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
Details
- Recall number
- Z-2446-2015
- Initiated
- July 14, 2015
- Posted by FDA
- August 21, 2015
- Terminated
- January 19, 2016
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 82 fluid packs
- Distribution
- US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2447-2015 Class II | cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC…Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a… | 07/14/2015Terminated |