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Terminated

K-Assay Lp(a) Control

FDA Recall Z-0940-04 · Posted 2004-07-20

Recalling FirmKamiya Biomedical Company
Recall StatusTerminated
Product CodeDFC
Date Initiated2004-03-29
Date Terminated2004-07-09
Product Quantity16

Reason for Recall

Assay result not consistent with the assigned control value

Firm Action

On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests return of the product.

Root Cause

Other

Distribution Pattern

The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023853K-ASSAY LP(A) CONTROLSKamiya Biomedical Co. · 2002-12-13

Official Source

View FDA Recall →

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

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