Use caution Medical device recall · FDA · Published November 14, 2019

Abbott Precision Xtra Recall: Infection Risk from Uncleared Disinfection Instructions

Abbott recalls Precision Xtra meters due to uncleared disinfection instructions that may cause infection. Check your device UDI and follow safety guidelines.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1556-2020Medical device Abbott ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAbbott Diabetes Care, Inc.1360 S Loop Rd · Alameda, CA 94502-7000

✎ GovInfoNow plain-language explainer

Abbott Diabetes Care, Inc. is recalling the Precision Xtra Blood Glucose & Ketone Monitoring System because the instructions for disinfecting the device were distributed without FDA clearance. Additionally, the devices were not cleared for use on multiple patients. These issues could lead to improper handling of contaminated meters and potentially cause infections. Read more at govinfonow.com/recall/66520-abbott-diabetes-care-precision-xtra-blood-glucose-system-recall-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/66520-abbott-diabetes-care-precision-xtra-blood-glucose-system-recall-infection · Updated October 13, 2026 · FDA enforcement record: FDA #Z-1556-2020

Cite this page

“Abbott Precision Xtra Recall: Infection Risk from Uncleared Disinfection Instructions.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/66520-abbott-diabetes-care-precision-xtra-blood-glucose-system-recall-infection. Based on FDA recall #Z-1556-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1556-2020%22&limit=1).

The FDA announced on 2019-11-14 that Abbott Diabetes Care, Inc. is recalling the Precision Xtra Blood Glucose & Ketone Monitoring System because its disinfection instructions were not cleared by the agency and devices were not cleared for multiple-patient use. The hazard poses a risk of infection or exacerbation of an existing infection due to inappropriate meter disinfection or improper handling of contaminated meters.

How to tell if you have it

Brand: Abbott
Product: Precision Xtra Blood Glucose & Ketone Monitoring System
UDI: 00093815715023, 00093815988144

The hazard

The recall addresses instructions for disinfecting blood glucose and/or ketone meters that were distributed but not cleared by the U.S. FDA. Devices were also not cleared for multiple-patient use. These issues may cause infection or exacerbation of an existing infection.

Context

GovInfoNow's records show Abbott Diabetes Care, Inc. has issued five other recalls since 2023-02-09. Recent similar recalls include the FreeStyle Libre 3 Plus Sensor Recall on 2025-11-24 and the FreeStyle Libre 3 Sensors recall on 2024-07-24. Other recent recalls of similar products include the Dexcom G7 Sensors recall (2026-05-27), the Medtronic MiniMed 640G Insulin Pump recall (2026-07-13), and the Medline Convenience Kits recall (2026-07-10).

How to tell if you have this one

Look for the Precision Xtra Blood Glucose & Ketone Monitoring System with Universal Device Identifier (UDI) numbers 00093815715023 or 00093815988144. The record does not list specific model or lot numbers, so check the UDI on your device. These units were distributed in multiple U.S. states including 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, and VA.

Brand
Abbott
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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

Recall number	Product, codes & lots
Z-1556-2020	Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144; Not associated with specific model/lot numbers.
Z-1557-2020	Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653; Not associated with specific model/lot numbers.
Z-1558-2020	FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810; All lots.

Based on the official FDA remedy

What to do — step by step

Review Disinfection Instructions
Check if you have the uncleared instructions for disinfecting your meter that were sent in a letter or included with the device.
Verify Device UDI
Confirm if your device has UDI 00093815715023 or 00093815988144.
Contact Abbott for Remedy
The recall record does not specify the remedy steps, so contact Abbott Diabetes Care directly for further instructions on what to do with your device.

Where it went and when

Where it was distributed

Distributed in 31 states and D.C..

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Nov 14, 2019Firm started the recall
Mar 23, 2020FDA classified it Class II
Apr 1, 2020Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where were these devices sold?

The devices were distributed in numerous U.S. states including Kentucky, New York, Tennessee, Massachusetts, Illinois, South Carolina, Vermont, Florida, California, North Carolina, Mississippi, New Jersey, Texas, Alabama, Georgia, Oklahoma, Connecticut, Pennsylvania, Nebraska, North Dakota, Montana, Missouri, DC, Maine, Louisiana, Kansas, Idaho, Ohio, Minnesota, New Mexico, and Virginia.

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Link to this recall

<a href="https://govinfonow.com/recall/66520-abbott-diabetes-care-precision-xtra-blood-glucose-system-recall-infection">Abbott Precision Xtra Recall: Infection Risk from Uncleared Disinfection Instructions (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1556-2020 (November 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1556-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.