VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The 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 lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. WC0181H, WC0181J, WC0181K
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accumetrics Inc
- Reason for Recall:
- Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The 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 lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Product Codes/Lot Numbers:
Lot No. WC0181H, WC0181J, WC0181K
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0482-2014
Related Recalls
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.
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic