Date Initiated by Firm | December 29, 2003 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on February 20, 2004 |
Recall Number | Z-0335-04 |
Recall Event ID |
27989 |
510(K)Number | K945915 K954018 K972733 K990092 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product | Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | 800-526-2272 |
Manufacturer Reason for Recall | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. |
FDA Determined Cause 2 | Other |
Action | A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types. |
Distribution | United States. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JJE
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