FDA Device recall Z-1557-2020
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 by Abbott Diabetes Care, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1557-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-14 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Diabetes Care |
| Distribution | AL, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT |
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.
Identifiers
| code_info | Not associated with specific model/lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1557-2020%22
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