Recall Z-1597-2022— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1597-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Class II · Ongoing

Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. It names one FDA 510(k) clearance: K052549. Product: MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762. Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Initiated: 2022-05-25
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·cleared 2005-10-06

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

MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762

Reason for recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

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