Hemochron Jr — Class II medical device recall Z-0937-2014
Terminated recall by ITC-Nexus Dx, reported 2014-02-12, distributed nationwide. ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individu
| Recall number | Z-0937-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ITC-Nexus Dx, Edison, NJ, United States |
| Recall initiated | 2013-12-19 |
| Classified | 2014-02-06 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, EE, ES, IT, RS |
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 individual patient heparin sensitivity.
Reason for recall
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
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-0937-2014. 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.