Recall Z-1583-2022— Mckesson Medical-Surgical Inc. Corporate Office
Class II · Ongoing
Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. It names 2 FDA 510(k) clearances: K183255, K093243. 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.. Reason: 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..
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-25
- Firm location
- Richmond, VA, United States
510(k) clearances named in this recall
2 on FDA's record- K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
- K093243 — COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.