Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VerifyNow IIb/IIIa Test Recalled by Accumetrics Inc Due to Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because...

Date: November 14, 2013
Company: Accumetrics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accumetrics Inc directly.

Affected Products

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.

Quantity: 69 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Accumetrics Inc

Accumetrics Inc has 4 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report