Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The pro
FDA device recall Z-1016-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- Reason for recall
- Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
- Action taken
- On 1/23/09, the firm issued an Advisory Notice to all its direct consignees, informing them of the affected product and providing instructions on the recall. Please contact BioGenex Technical Support at 1-800-421-4149 for any assistance you may need.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KEY
- Quantity affected
- 12 units
- Distribution
- The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the pro
- Date initiated
- 2009-01-23
- Date posted
- 2010-03-08
- Date terminated
- 2010-12-02
- Location
- San Ramon, CA
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