Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Incorrect Instructions
Accumetrics is recalling VerifyNow IIb/IIIa Test Kits because they contain incorrect instructions regarding the time limit for performing the test after sample collection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect labeling/instructions which could lead to improper test execution, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Accumetrics Inc is recalling the VerifyNow IIb/IIIa Test, 10-Test Kit (Catalog No. 85310). The recall involves 69 units, specifically Lot Nos. WC0181H, WC0181J, and WC0181K. The product 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.
The recall was initiated because the test kits contain incorrect information regarding the amount of time in which to perform the test following the collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
The affected units were distributed nationwide, including in New York, Pennsylvania, the District of Columbia, Connecticut, Indiana, New Jersey, Arkansas, Texas, Arizona, and New Mexico. Clinicians and laboratories should stop using the affected test kits and contact Accumetrics Inc for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Accumetrics Inc
- Hazard
- Affected units
- 69
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot No. WC0181H
- WC0181J
- WC0181K
Distribution
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