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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm December 16, 2002
Date Posted January 23, 2003
Recall Status1 Terminated 3 on March 19, 2003
Recall Number Z-0438-03
Recall Event ID 25169
Product delete. created in error
Code Information none
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-5074
Manufacturer Reason
for Recall		 Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
FDA Determined
Cause 2		 Other
Action An urgent device correction letter dated 12/16/02 was sent to each customer. The letter advised of the problem and instructed customers to follow a strict quality control regime to ensure proper electrode performance. Customers were instructed how to automatically lock the affected parameter so that patient results will not be reported if QC performance violates the customer''s programmed rules.
Distribution United States
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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