Reported Jul 30, 2014 · Terminated

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog…

ITC-Nexus Dx

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: ITC-Nexus Dx · 23 Nevsky St · Edison, NJ · 08820-2425

Is this the product you have?

  • Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Lot codes and dates
  • Lot Number A4JCA001
Amount recalled
US- 315 cuvettes; OUS - 2835 cuvettes

Where it was sold

Why it was recalled

Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

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

Notice updated Dec 11, 2014 · Data as of Sep 19, 4:50 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.