BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGen
FDA device recall Z-1438-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- 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).
- Action taken
- On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.
- Root cause
- Other
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 96 units for both Recalls Z-1438/1439-06
- Distribution
- Nationwide
- Date initiated
- 2006-06-02
- Date posted
- 2006-08-29
- Date terminated
- 2006-11-17
- Location
- San Ramon, CA
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