Paradigm Link -- Blood Glucose Monitor.
FDA device recall Z-0562-06 · posted 2006-02-25 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
- Action taken
- Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 227,240 units
- Distribution
- The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include location
- Date initiated
- 2006-01-05
- Date posted
- 2006-02-25
- Date terminated
- 2006-09-05
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (K041478) | Becton Dickinson | 2004-10-28 |