Z-1016-2010

Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number...

Name: Z-1016-2010 Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number...
Creator: Biogenex Laboratories
Published: 2009-01-23
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2009-01-23 / Terminated / root cause: design

FDA source

Biogenex Laboratories began a recall of Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex... on 2009-01-23. The reason FDA records is "Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1016-2010
Status: Terminated
Initiated: 2009-01-23
Posted: 2010-03-08
Terminated: 2010-12-02
Recalling firm: Biogenex Laboratories, Inc.
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.
Product code: KEY Stainer, Tissue, Automated
Reason for recall: Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237

Product code KEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)