Date Initiated by Firm | March 28, 2005 |
Date Posted | October 28, 2005 |
Recall Status1 |
Terminated 3 on April 06, 2006 |
Recall Number | Z-0099-06 |
Recall Event ID |
31372 |
510(K)Number | K930454 K942884 K952625 K974569 |
Product Classification |
Test, Time, Prothrombin - Product Code GJS
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Product | Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact | 800-428-4674 |
Manufacturer Reason for Recall | Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions. |
Quantity in Commerce | unknown. |
Distribution | Nationwide. |
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 = GJS
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