Device 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.
Z-0937-2014
Product summary
- Firm
- ITC-Nexus Dx
- Event
- Event 67237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
- Official record key
device-enforcement:Z-0937-2014
Official wording
Reason: ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Code information: E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Derived failure modes
-
Unknown
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.