FDA-Device2026-01-21Class II
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Instrumentation Laboratory
Hazard
Potential for microbial contamination.
Sold states
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.
Affected count
7,720 units
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2026Don't want to check this manually?
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