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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas b 123 POC system

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 Class 2 Recall
Cobas b 123 POC system
see related information
Date Posted December 13, 2012
Recall Status1 Terminated on August 07, 2013
Recall Number Z-0522-2013
Recall Event ID 63680
Premarket Notification
510(K) Number
K111188 
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
Code Information Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis, Indiana 46256-1025
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Todd Siesky
317-576-2000 Ext. 249
Manufacturer Reason
for Recall
It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272. For questions regarding this recall call 317-521-3966.
Quantity in Commerce 23 units of Fluid Pack COOX, 200 were distributed
Distribution Nationwide Distribution including NE and AZ.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = ROCHE DIAGNOSTICS
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