| Date Initiated by Firm | June 22, 2006 |
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| Date Posted | August 05, 2006 |
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| Recall Status1 |
Terminated 3 on April 07, 2008 |
| Recall Number | Z-1359-06 |
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| Recall Event ID |
35022 |
| 510(K)Number | K930979 |
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| Product Classification |
Blood Glucose Meter - Product Code CGA
|
| Product | ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number 2138930. |
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| Code Information |
All units. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
|
| For Additional Information Contact |
800-440-3638 |
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Manufacturer Reason
for Recall | The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error. |
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FDA Determined
Cause 2 | Other |
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| Action | A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available. |
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| Quantity in Commerce | 55,189 meters (for all Recalls Z-1354-1371-06) |
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| Distribution | Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = CGA
|
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