FDA recall Z-0921-2025

Product

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

Reason for recall

The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.

Distribution

Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.

Key facts

Status

Ongoing

Initiation date

2024-10-07

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Springfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2025