Unistrip Technologies Recalls Blood Glucose Test Strips for Labeling Changes
Unistrip Technologies LLC is recalling 7,175 units of UniStrip1 Blood Glucose Test Strips because the company failed to submit a 510(k) for device labeling changes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the cause as a failure to submit a 510(k) for labeling changes, which aligns with the rubric's criteria for minor labeling errors or documentation issues.
Plain-English summary
Unistrip Technologies LLC is recalling 7,175 units of UniStrip1 Blood Glucose Test Strips, 50 count boxes. These test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
The recall was initiated because the company failed to submit a 510(k) for device labeling changes. The affected units were distributed in the United States to the states of Florida and Ohio. The specific lot codes involved are U14030713, 814031313, U140312323, and U14031413.
Consumers who have these specific test strips should stop using them and contact Unistrip Technologies LLC for further instructions.
The recalled product
- 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 the effectiveness of diabetes control.
- Manufacturer
- Unistrip Technologies LLC
- Hazard
- Affected units
- 7,175
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- U14030713
- 814031313
- U140312323
- and U14031413.
Distribution
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