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.
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Coag-Sense Professional Blood Coagulation Test kits (PT/INR) used to measure blood clotting time. The recall affects specific lot codes distributed between May 30, 2021 and August 24, 2021. The kits were exposed to higher-than-recommended temperatures at a facility between June and August 2021 before being shipped, which may have reduced the product's effectiveness.
The affected test kits were distributed nationwide. Consumers or healthcare facilities with these products should identify whether they received kits from the recalled lot codes during the specified timeframe. The recall notice does not specify a remedy or instructions for what consumers should do with recalled products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide Quantity: a. 27 boxes b. 1 box Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.