ITC-Nexus Dx Recalls Hemochron Jr. APTT Cuvettes Due to Test Errors
ITC-Nexus Dx is recalling Hemochron Jr. APTT cuvettes because they may produce erroneously elevated test results or out-of-range high error codes in non-heparinized blood samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic test errors (erroneously elevated results or error codes) rather than direct physical injury or contamination, and no illnesses or injuries are reported in the source text.
Plain-English summary
ITC-Nexus Dx is recalling Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvettes, catalog number J103, lot number A4JCA001. The recall involves 315 cuvettes distributed in the United States and 2,835 cuvettes distributed outside the United States.
The recall is being issued because the cuvettes may cause test results to be erroneously elevated or report an out-of-range high (OOR-H) error code when used with non-heparinized blood samples. This issue affects in vitro diagnostic coagulation testing.
The affected products were distributed worldwide, including in the United States (specifically Georgia, Virginia, and New York) and in Canada, France, Italy, Liechtenstein, and Romania. Users of these products should stop using the affected lot and contact ITC-Nexus Dx for further instructions.
The recalled product
- Product
- Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
- Manufacturer
- ITC-Nexus Dx
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number A4JCA001
Distribution
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