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Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results. Recalled by Abbott Diabetes Care, Inc.. Distribution: U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.. Classification (Class I — serious health hazard). Affected lots/dates: Model Number: 78769-01 UDI-DI Code: 00357599843014 Product Expiry Date: 0

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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