Mckesson Medical-Surgical Inc. Corporate Office: Medical Device Recall in 2022 - (Recall #: Z-1583-2022)

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. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10.

Product Classification:

Class II

Date Initiated: May 25, 2022

Date Posted: August 31, 2022

Recall Number: Z-1583-2022

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. 27 boxes b. 1 box

Code Information:

a. GTIN: 00861900000336; 10861900000395; 00861900000398. Lot codes distributed between 5/30/2021 - 8/24/2021. b. GTIN 00861900000343 Lots Distributed: 8/20/2021 - 8/20/2021

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated