FDA-Device2026-01-21Class IIPACKAGING DEFECT
Instrumentation Laboratory coagulation test reagent recalled for microbial contamination risk
What this means
Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.
- Check if your laboratory has reagent Lot N1136730 with the listed Part Number
- Do not use the product if you have this lot
- Contact Instrumentation Laboratory or your supplier for instructions on return or disposal
- Review any test results from this lot with your healthcare provider if medically necessary
The agency's original wording
Hazard
Potential for microbial contamination.
Intended for
Adults
Illnesses reported
None reported
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-1095-2026Want us to check the next one for you?
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