Reported Aug 31, 2022 · Ongoing
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233
Is this the product you have?
- 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.
- Lot codes and dates
- a
- GTIN00861900000336; 10861900000395; 00861900000398. Lot codes distributed between 5/30/2021 - 8/24/2021. b
- GTIN 00861900000343 Lots Distributed8/20/2021 - 8/20/2021
- Amount recalled
- a. 27 boxes b. 1 box
This recall covers 55 products
The agency filed one notice per product. You are reading one of them; the other 54 are below.
42 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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