⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Instrumentation Laboratory: The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Medical DevicesSource: FDA (device) · Date: 2026-01-21

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Instrumentation Laboratory
Product
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Reason / hazard
Potential for microbial contamination.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-12-11
Code info
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Product quantity
7,720 units
Voluntary mandated
Voluntary: Firm initiated
City
Bedford
State
MA
Country
United States
Event id
98166
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