FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
- Recall number
- Z-1558-2020
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
- Status
- Terminated
- Initiated
- 2019-11-14
- Posted
- 2020-02-28
- Terminated
- 2021-04-28
- Reason
- 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
- 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.
- Quantity
- not on file
- 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
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K060768","K070984"]
- PMA numbers
- not on file
- Product code
- JIN
- Firm FEI
- 3002803444
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28