Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Reported: April 1, 2020 Initiated: November 14, 2019 #Z-1557-2020
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.
Details
- Recalling Firm
- Abbott Diabetes Care, Inc.
- Units Affected
- N/A
- 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
- Location
- Alameda, CA
Frequently Asked Questions
What product was recalled? ▼
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653. Recalled by Abbott Diabetes Care, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1557-2020.
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