Recall Z-1557-2020— Abbott Diabetes Care, Inc.

Name: FDA recall Z-1557-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-14

Class II · Terminated

Class II FDA medical device recall by Abbott Diabetes Care, Inc., initiated 2019-11-14, terminated 2021-04-28. It names one FDA 510(k) clearance: K081975. Product: Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653. 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

1 on FDA's record

K081975 — RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)Abbott Diabetes Care, Inc.·cleared 2008-11-26

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

Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653

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.