# FDA recall Z-1558-2020

> **Abbott Diabetes Care, Inc.** · Class II · device recall initiated 2019-11-14.

## 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

- **Recall number:** Z-1558-2020
- **Recalling firm:** Abbott Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1558-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1558-2020. Source: US FDA. Licensed CC0.

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