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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biogenex Laboratories
Lot Codes / Batch Numbers
Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
Products Sold
Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
Biogenex Laboratories is recalling Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Numb due to Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026