Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended f
FDA device recall Z-1140-2013 · posted 2013-04-18 · Terminated
Recall details
- Recalling firm
- Nipro Diagnostics, Inc.
- Reason for recall
- Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
- Action taken
- NIPRO Diagnostics sent a Voluntary Product Field Action Notice dated August 12, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check with all Duane Reade retail locations and Duane Reade Disgtribution Center to determine if they have any of the affected product ath their location. If product is located customers were instructed to call 1-800-803-6049 for a Return Authorization Number and instructions for returning the affected product. For questions regarding this recall call 954-677-9201.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 1,627 Kits
- Distribution
- Nationwide Distribution only in NY.
- Date initiated
- 2013-02-25
- Date posted
- 2013-04-18
- Date terminated
- 2013-07-08
- Location
- Ft Lauderdale, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) (K032657) | Home Diagnostics, Inc. | 2004-03-24 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS (K030703) | Home Diagnostics, Inc. | 2003-07-11 |