FDA recall Z-0138-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.

Reason for recall

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.

Distribution

US Nationwide distribution in the state of DC.

Key facts

Status
Ongoing
Initiation date
2024-09-17
Report date
2024-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0138-2025