Device product
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Z-1095-2026
Product summary
- Event
- Event 98166
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,720 units
- Official record key
device-enforcement:Z-1095-2026
Official wording
Reason: Potential for microbial contamination.
Code information: Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
Derived failure modes
-
Microbial contamination
microbial contamination