Z-1095-2026 Class II Ongoing
FDA device recall Z-1095-2026 was initiated by Instrumentation Laboratory on December 11, 2025 and is designated Class II. Reason for recall: Potential for microbial contamination. The recall status is ongoing. Affected quantity: 7,720 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- December 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,720 units
Product Description
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Reason for Recall
Potential for microbial contamination.
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.
Code Information
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.