FDAFDA · Food and drugs·Recall number Z-1583-2022
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.
Published August 31, 2022 · Recall initiated: May 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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