Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
FDA device recall Z-1471-2008 · posted 2008-08-22 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- Reason for recall
- Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
- Action taken
- The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KEY
- Quantity affected
- 10 units distributed.
- Distribution
- Product was distributed to a single distributor, which further distributed the product.
- Date initiated
- 2008-01-24
- Date posted
- 2008-08-22
- Date terminated
- 2011-01-08
- Location
- San Ramon, CA
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