Class 2 Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems

• Date Initiated by Firm: June 24, 2015
• Date Posted: August 05, 2015
• Recall Status: Terminated on January 12, 2016
• Recall Number: Z-2330-2015
• Recall Event ID: 71609
• 510(K)Number: K032311
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
• Code Information: Catalog Number: 03260925184; Lot Numbers & Exp. Dates: 1. 21450781, Exp. 08/31/2016 2. 21450887, Exp. 08/31/2016 3. 21451391, Exp. 09/30/2016
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Todd Siesky; 317-576-2000 Ext. 249
• Manufacturer Reason for Recall: The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.
• FDA Determined Cause: Process control
• Action: Roche Diagnostics sent an Urgent Medical Device Correction dated July 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to do the following: 1. Keep in the inventory a backup S2 Fluid Packs from an unaffected lot, or at least four additional S2 Fluid Packs from the affected lots when product from unaffected lots is not available. 2. If the S2 Fluid Pack generates a Transponder error message, contact the Roche Support Network Customer Support Center at 1-800-526-2272 (provide the lot and serial number printed on the side of the affected S2 Fluid Pack). 3. After contacting Roche Support Network Customer Support Center, dispose of the affected S2 Fluid Pack per local guidelines. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272, if you have questions about the information contained in this Urgent Medical Device Correction.
• Quantity in Commerce: 19 affected devices of lot 21450781 were distributed in the US.
• Distribution: US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
• 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