FDA Medical Device Recalls (openFDA)
Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
- Recall number
- Z-1471-2008
- Recalling firm
- Biogenex Laboratories
- Product
- Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
- Status
- Terminated
- Initiated
- 2008-01-24
- Posted
- 2008-08-22
- Terminated
- 2011-01-08
- Reason
- Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
- Root cause
- Component design/selection
- Action
- The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.
- Quantity
- 10 units distributed.
- Distribution
- Product was distributed to a single distributor, which further distributed the product.
- Lot, serial or model codes
- Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KEY
- Firm FEI
- 2936532
- Firm city
- San Ramon
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28