ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results
ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a diagnostic device that may produce inaccurate results, posing a risk of harm through misdiagnosis or improper treatment, but the source does not report specific injuries or hospitalizations.
Plain-English summary
ITC-Nexus Dx is recalling 25,965 Hemochron Jr. Citrate APTT Cuvettes. These unitized microcoagulation tests are intended for quantitative, one-stage APTT testing to evaluate low doses of heparin anticoagulant. The recall was initiated because the company determined that some of the cuvettes may recover higher than expected results in normal individuals.
The affected products were distributed worldwide, including nationwide in the United States and in Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain, and Saudi Arabia. The specific lot codes and expiration dates for the recalled units are E3JCC013-P1 (exp 2014-05), E3JCC014-P2 (exp 2014-05), F3JCC015-P3 (exp 2014-06), F3JCC016 (exp 2014-06), and H3JCC017 (exp 2014-08).
Healthcare providers and consumers should stop using these specific cuvettes and contact ITC-Nexus Dx for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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 individu
- Manufacturer
- ITC-Nexus Dx
- Category
- Medical Device — Diagnostic Test
- Hazard
Distribution
Distributed nationwide across the United States.
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