FDAFDA · Food and drugs·Recall number Z-0937-2014
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.
Published February 12, 2014 · Recall initiated: December 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ITC-Nexus Dx
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
- Lot
- E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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