Reported Oct 27, 2021 · Ongoing

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH)…

Instrumentation Laboratory

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443

Is this the product you have?

  • HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite
  • Pro/8/9/10000) Part Number0020302600
Lot codes and dates
  • All currently released lots and future lots
Amount recalled
64,114

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.