Reported Mar 19, 2014 · Terminated
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The…
Accumetrics Inc.
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: Accumetrics Inc · 3985 Sorrento Valley Blvd Ste B · San Diego, CA · 92121-1497
Is this the product you have?
VerifyNow IIb/IIIa TestCatalog No. 8531010-Test Kit and Catalog No. 8501125-Test kit
- Product UsageThe VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician
- Lot codes and dates
Lot/Serial No. WC0182BWC0182CWC0182AWC0182DWC0182EWC0182FWC0182GWC0180CWC0180EWC0180FWC0181AWC0181CWC0181DWC0181FWC0180AWC0180BWC0180DWC0181BWC0181EWC0181GWC0181HWC0181JWC0181K
- Amount recalled
- 576 units total (524 units in US)
Where it was sold
- Nationwide
Why it was recalled
Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
This product could cause temporary or reversible health problems — stop using it.
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