Z-1558-2020Class II

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

Name: Z-1558-2020 FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Creator: Abbott Diabetes Care, Inc.
Published: 2019-11-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-11-14 / Terminated / root cause: labeling and UDI

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 on 2019-11-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1558-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Posted: 2020-02-28
Terminated: 2021-04-28
Recalling firm: Abbott Medical
Product: FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Product code: JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
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 codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1558-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1556-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-23
Z-1557-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-23
Z-1558-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-23

Product code JIN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)