FDAFDA · Food and drugs·Recall number Z-1245-2013
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Published May 15, 2013 · Recall initiated: April 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Abbott Diabetes Care, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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