BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomed
FDA device recall Z-1221-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Test Strips may not be meeting specifications at the lower range of glucose values.
- Action taken
- On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 754800 strips
- Distribution
- Product was distributed to the Becton Dickinson Canada, Inc.,
- Date initiated
- 2003-07-23
- Date posted
- 2003-09-11
- Date terminated
- 2004-12-02
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM (K022580) | Becton, Dickinson & CO | 2002-10-09 |
| BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM (K022581) | Becton, Dickinson & CO | 2002-10-09 |