| Date Initiated by Firm | November 09, 2005 |
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| Date Posted | January 24, 2006 |
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| Recall Status1 |
Terminated 3 on June 14, 2007 |
| Recall Number | Z-0419-06 |
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| Recall Event ID |
33862 |
| 510(K)Number | K043474 |
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| Product Classification |
Glucose Dehydrogenase, Glucose - Product Code LFR
|
| Product | Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.) |
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| Code Information |
For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-858-8072 |
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Manufacturer Reason
for Recall | Incorrect patient blood glucose test results may be reported due to a software problem. |
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FDA Determined
Cause 2 | Other |
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| Action | Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06. |
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| Distribution | Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden. |
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| 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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| 510(K) Database | 510(K)s with Product Code = LFR
|
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