Device 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.
Z-1583-2022
Product summary
- Event
- Event 90336
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a. 27 boxes b. 1 box
- Official record key
device-enforcement:Z-1583-2022
Official wording
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.
Code information: 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
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.