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Terminated

VerifyNow Asprin Assay Kit Part No. 85034

FDA Recall Z-1018-04 · Posted 2004-07-20

Recalling FirmAccumetrics Inc
Recall StatusTerminated
Product CodeJOZ
Date Initiated2004-05-10
Date Terminated2004-09-07
Product Quantity4500

Reason for Recall

Test results too low in control.

Firm Action

Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)Accumetrics, Inc. · 2002-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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