UniStrip1 recall: Labeling Error
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor…
Why was UniStrip1 recalled?
Failure to submit a 510(k) for device labeling changes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
U14030713, 814031313, U140312323, and U14031413.
- Product
- UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor…
- Recalling firm
- Unistrip Technologies LLC
- Quantity
- 7175 units
- Distribution
- US Distribution to the states of FL and OH.
- Recall date
- December 31, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)