FDA Device recall Z-0937-2014
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -s…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -s… by Itc Nexus Dx, citing ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0937-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-19 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Itc Nexus Dx |
| Distribution | US |
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
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Identifiers
| code_info | E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08 |
|---|
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-0937-2014%22
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