Recall Z-1606-2022— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1606-2022
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 2 FDA 510(k) clearances: K062361, K993203. Product: a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.. 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

2 on FDA's record

K062361 — INNOVACON HCG UKTRA TEST DEVICEInnovacon, Inc.·cleared 2006-10-23
K993203 — ACON ONE STEP PREGNANCY TEST STRIP (URINE)ACON Laboratories, Inc.·cleared 1999-12-01

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

a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

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.