Reported Feb 12, 2014 · Terminated
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a…
ITC-Nexus Dx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ITC-Nexus Dx · 23 Nevsky St · Edison, NJ · 08820-2425
Is this the product you have?
- 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.
- Lot codes and dates
- E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
- Amount recalled
- 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Where it was sold
- Nationwide
Why it was recalled
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
This product could cause temporary or reversible health problems — stop using it.
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