VerifyNow P2Y12 Assay Device Kit, Part Number 85054
FDA Recall Z-0228-2007 · Posted 2006-12-06
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Recalling FirmAccumetrics Inc
Recall StatusTerminated
Product CodeJOZ
Date Initiated2006-09-05
Date Terminated2012-03-26
Product Quantity333
Reason for Recall
The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
Firm Action
The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter.
The notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.
Root Cause
Other
Distribution Pattern
Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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