Recall Z-1438-06 ยท MVU Reagents, Specific, Analyte
Biogenex Laboratories
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
| Date | Aug 29, 2006 (initiated Jun 2, 2006) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Other |
| Action | On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed. |
| Quantity | 96 units for both Recalls Z-1438/1439-06 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.