Recall Z-1558-2020— Abbott Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Diabetes Care, Inc., initiated 2019-11-14, terminated 2021-04-28. It names 2 FDA 510(k) clearances: K070984, K060768. Product: FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810. 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..
- Recalling firm
- Abbott Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-14
- Terminated
- 2021-04-28
- Firm location
- Alameda, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K070984 — THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
- K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.