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Terminated

FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810

FDA Recall Z-1558-2020 · Posted 2020-02-28

Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeJIN
Date Initiated2019-11-14
Date Terminated2021-04-28

Reason for Recall

Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.

Firm Action

On 11/14/19, Urgent Medical Device Correction notices were mailed to customers via overnight delivery. Customers were told to continue to use instructions for use regarding the cleaning of meters for use on single patients only. Customers were further asked to complete and return customer response forms. Customers with additional questions were encouraged to call customer service in 1-888-522-5226.

Root Cause

Labeling False and Misleading

Distribution Pattern

U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070984THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPSAbbott Diabetes Care, Inc. · 2007-11-01K060768PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPSAbbott Diabetes Care, Inc. · 2006-04-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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