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All product recalls associated with Lifescan Inc.
Total Recalls
18
Past Year
0
Class I (Serious)
0
Most Recent
Nov 2008
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
Product may be defective and may give low inaccurate glucose results.
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do you need a snack?' for glucose values from 20 through 59 mg/dL.
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.