FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Reported: June 30, 2021 Initiated: March 16, 2021 #Z-1931-2021
Product Description
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Reason for Recall
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 2,115 kits
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877. Recalled by Cardinal Health Inc.. Units affected: 2,115 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1931-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11