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Terminated

BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583

FDA Recall Z-1438-06 · Posted 2006-08-29

Recalling FirmBiogenex Laboratories
Recall StatusTerminated
Product CodeMVU
Date Initiated2006-06-02
Date Terminated2006-11-17
Product Quantity96 units for both Recalls Z-1438/1439-06

Reason for Recall

Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR).

Firm Action

On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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