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Mckesson Medical-Surgical Inc. Corporate Office recalls a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Te
Recalled August 31, 2022 · FDA recall Z-1583-2022 · Mckesson Medical-Surgical Inc. Corporate Office
Hazard
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. · FDA Class II
Units
a. 27 boxes b. 1 box
Sold at
US Nationwide
Description
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.
Product
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.
Manufacturer(s)
Mckesson Medical-Surgical Inc. Corporate Office
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →