Mckesson Medical-Surgical Inc. Corporate Office: Medical Device Recall in 2022 - (Recall #: Z-1606-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 25, 2022

Date Posted: August 31, 2022

Recall Number: Z-1606-2022

Event ID: 90336

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.

Status: Ongoing

Product Quantity: a. 5 kits b. 12 kits

Code Information:

GTIN: a. 10815845020130; 00815845020133. b. 10815845020093, 00815845020096

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated