FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
FDA device recall Z-1558-2020 · posted 2020-02-28 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- JIN
- 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
- Date initiated
- 2019-11-14
- Date posted
- 2020-02-28
- Date terminated
- 2021-04-28
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS (K070984) | Abbott Diabetes Care, Inc. | 2007-11-01 |
| PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (K060768) | Abbott Diabetes Care, Inc. | 2006-04-21 |