FreeStyle Precision H Blood Glucose and Ketone Monitoring… recallZ-1558-2020 · Abbott Diabetes Care, Inc. · initiated Nov 14, 2019
Class II Terminated All recalls posted in February 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
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.
Recall details
- Recall number
- Z-1558-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 14, 2019
- Posted by the FDA
- Feb 28, 2020
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product code
- JIN
- FDA submissions
- K060768, K070984
- 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
Product description
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Code information (models, lots, serial numbers)
All lots.
Other devices under the same FDA submission
3 devices cleared under K060768, K070984 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FreeStyle Precision H 80116Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose2 reports
- Precision Xtra 70745Abbott Diabetes Care Inc · NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)1 report
- FreeStyle Precision H 71181Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 84866).
- Z-1556-2020 · TerminatedPrecision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
- Z-1557-2020 · TerminatedOptium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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