FDA recall Z-0357-2025

Product

URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581

Reason for recall

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

Key facts

Status

Ongoing

Initiation date

2024-10-23

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2025