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U.S. Department of Health and Human Services

Class 2 Device Recall Osmetech OPTICCA, EGlu Cassettes

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  Class 2 Device Recall Osmetech OPTICCA, EGlu Cassettes see related information
Date Initiated by Firm June 22, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on January 12, 2005
Recall Number Z-1064-04
Recall Event ID 29393
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTI¿E-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
Code Information All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603.
Recalling Firm/
Manufacturer		 Osmetech Inc
235 Hembree Park Dr
Roswell GA 30076-5700
For Additional Information Contact Dan McMinn
770-510-4444 Ext. 573
Manufacturer Reason
for Recall		 In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 6/22/04. A separate Recall Notice was mailed to distributors outside the United States with instructions on issuing the recall notice to their affected customers in the appropriate language.
Quantity in Commerce 1087 boxes
Distribution Nationwide and Argentina, Austria, Bolivia, France, Greece, Germany, Korea, India, Italy, Jordan, Netherlands, Sweden, Switzerland.
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.
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