Z-1471-2008

Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B

Name: Z-1471-2008 Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Creator: Biogenex Laboratories
Published: 2008-01-24
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2008-01-24 / Terminated / root cause: design

FDA source

Biogenex Laboratories began a recall of Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B on 2008-01-24. The reason FDA records is "Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals". 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-1471-2008
Status: Terminated
Initiated: 2008-01-24
Posted: 2008-08-22
Terminated: 2011-01-08
Recalling firm: Biogenex Laboratories, Inc.
Product: Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Product code: KEY Stainer, Tissue, Automated
Reason for recall: Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
Root cause tag: design
FDA 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 in commerce: 10 units distributed.
Distribution: Product was distributed to a single distributor, which further distributed the product.
Product codes and lots: Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.

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)