FDA Device recall Z-1930-2021
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
- FDA Device
- Class II
- ongoing
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 by Cardinal Health, citing due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1930-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-16 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Reason
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Identifiers
| code_info | NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1930-2021%22
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