Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation Recalled by ITC-Nexus Dx Due to ITC has determined that some Citrate APTT cuvettes...

Date: December 19, 2013
Company: ITC-Nexus Dx
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ITC-Nexus Dx directly.

Affected Products

Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

Quantity: 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)

Why Was This Recalled?

ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ITC-Nexus Dx

ITC-Nexus Dx has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report