Device product
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Z-0880-2026
Product summary
- Event
- Event 97942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20250
- Official record key
device-enforcement:Z-0880-2026
Official wording
Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Code information: UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Distribution pattern: Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.
Derived failure modes
-
Foreign material or chemical contamination
foreign object