Hemochron Jr — Class II medical device recall Z-2088-2014
Terminated recall by ITC-Nexus Dx, reported 2014-07-30, distributed in GA, NY, VA. Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized
| Recall number | Z-2088-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ITC-Nexus Dx, Edison, NJ, United States |
| Recall initiated | 2014-06-20 |
| Classified | 2014-07-21 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-12-11 |
| Distributed | GA, NY, VA |
| Countries outside the US | CA, FR, IT, RO |
| Lot numbers | A4JCA001 |
| Model numbers | J103 |
Product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Reason for recall
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2088-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.