Mckesson Medical-Surgical Inc. Corporate Office: Medical Device Recall in 2024 - (Recall #: Z-1312-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

Product Classification:

Class II

Date Initiated: January 9, 2024

Date Posted: March 27, 2024

Recall Number: Z-1312-2024

Event ID: 94024

Reason for Recall:

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Status: Ongoing

Product Quantity: 3 units

Code Information:

Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;

Distribution Pattern:

US Nationwide distribution in the states of AZ, PA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated