FDA Device recall Z-2088-2014
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette by Itc Nexus Dx, citing test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2088-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-20 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Itc Nexus Dx |
| Distribution | GA, NY, VA |
Product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Reason
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Identifiers
| code_info | Lot Number A4JCA001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2088-2014%22
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