Recall Z-1172-2014
Accumetrics Inc · initiated February 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: Lot/Serial No. WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Accumetrics sent an Urgent Medical Device Recall letter dated February 13, 2014 to all affected customers. The recall letter informs the customers of the problems identified and the actions to be taken. Cusotomers are instructed to complete the attached Customer Account Tracking Form and return it within 10 days by fax, email or mail. Customers with questions are instructed call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com.
Details
- Recall number
- Z-1172-2014
- Initiated
- February 13, 2014
- Posted by FDA
- March 11, 2014
- Terminated
- August 23, 2014
- Product code
- JOZ – System, Automated Platelet Aggregation
- Quantity
- 576 units total (524 units in US)
- Distribution
- USA Nationwide Distribution
- Recalling firm
- Accumetrics Inc, San Diego, CA