Abbott Diabetes Care, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1558-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 14, 2019

Date Posted: April 1, 2020

Recall Number: Z-1558-2020

Event ID: 84866

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.

Status: Terminated

Product Quantity: N/A

Code Information:

All lots.

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

Voluntary or Mandated:

Voluntary: Firm initiated