FDA recall Z-1558-2020

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-11-14

Report date

2020-04-01

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alameda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2020