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 the effectiveness of diabetes control.
FDA Recall Z-0855-2015 · Posted 2014-12-23
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Recalling FirmUnistrip Technologies LLC
Recall StatusTerminated
Product CodeNBW
Date Initiated2014-11-20
Date Terminated2015-05-20
Product Quantity7175 units
Reason for Recall
Failure to submit a 510(k) for device labeling changes.
Firm Action
UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.
Root Cause
No Marketing Application
Distribution Pattern
US Distribution to the states of FL and OH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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