Recall Z-0138-2025— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-0138-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-17

Class II · Ongoing

Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2024-09-17. It names one FDA 510(k) clearance: K874890. 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: 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..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Initiated: 2024-09-17
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K874890 — QUANTIMETRIX URINE DIPSTICK CONTROLQuantimetrix Medical Industries·cleared 1988-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.