Class 2 Device Recall Roche cobas b 123 POC system

• Date Initiated by Firm: July 14, 2015
• Date Posted: August 21, 2015
• Recall Status: Terminated on January 19, 2016
• Recall Number: Z-2446-2015
• Recall Event ID: 71786
• 510(K)Number: K111188
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• 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.
• Code Information: 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)
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Todd Siesky; 317-576-4343
• Manufacturer 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: 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.
• Quantity in Commerce: 82 fluid packs
• Distribution: US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CHL and Original Applicant = Roche Diagnostics