FDA · Medical device recall
One Touch Ultra Blood Glucose test strips…
- Date posted by the FDA
- Jan. 5, 2007
- Status
- Terminated
- Filed by
- Discount Diabetic Supply
- Product
- One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips
- Reason
- Counterfeit-blood glucose test strips (manufacturer unknown)
- Distribution pattern
- Nationwide distribution --- States of CA, TX, TN, GA, AL, and OK
- Quantity
- 240 units
- Codes and lots
- Lot No. 2691191
- Recall started
- Oct. 19, 2006
- Device type
- System, Test, Blood Glucose, Over The Counter
- Root cause (FDA)
- Other
- What the company told customers
- The recalling firm notified its consignees of the problem and the recall by telephone on 10/19/2006. The firm followed this with a written notice on 10/30/2006.
- Recall number
- Z-0206-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-0206-2007. The agency record governs; check it and the company before acting.