FDA Medical Device Recalls (openFDA)
Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.
- Recall number
- Z-1016-2010
- Recalling firm
- Biogenex Laboratories
- Product
- Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.
- Status
- Terminated
- Initiated
- 2009-01-23
- Posted
- 2010-03-08
- Terminated
- 2010-12-02
- Reason
- Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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 product is exclusive distributed by Abbott Molecular.
- Lot, serial or model codes
- Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
- 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