Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results
Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (erroneous clinical results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Accumetrics Inc is recalling the VerifyNow IIb/IIIa Test, including Catalog No. 85310 (10-Test Kit) and Catalog No. 85011 (25-Test Kit). The VerifyNow System is a turbidimetric optical detection system used to measure platelet-induced aggregation and glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide.
The recall was initiated because the test may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. This error may cause a low percent inhibition calculation or a low baseline PAU, which could impact the interpretation of clinical data.
A total of 576 units were distributed, with 524 units distributed within the United States. The affected lots include WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, and WC0181K. Healthcare facilities and distributors should stop using the affected units and contact Accumetrics for instructions on return or replacement.
The recalled product
- Product
- VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable t
- Manufacturer
- Accumetrics Inc
- Hazard
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 (20)
- Lot/Serial No. WC0182B
- WC0182C
- WC0182A
- WC0182D
- WC0182E
- WC0182F
- WC0182G
- WC0180C
- WC0180E
- WC0180F
- WC0181A
- WC0181C
- WC0181D
- WC0181F
- WC0180A
- WC0180B
- WC0180D
- WC0181B
- WC0181E
- WC0181G
Distribution
Distributed nationwide across the United States.
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