FDA recall Z-3054-2020

Product

Control, Calibrator Verified, Triage BNP, Model ALR88755

Reason for recall

Product was shipped with refrigeration (ice) instead of frozen (dry ice).

Distribution

Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX

Key facts

Status

Terminated

Initiation date

2020-07-28

Report date

2020-10-07

Termination date

2023-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3054-2020