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Terminated

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.

FDA Recall Z-1016-2010 · Posted 2010-03-08

Recalling FirmBiogenex Laboratories
Recall StatusTerminated
Product CodeKEY
Date Initiated2009-01-23
Date Terminated2010-12-02
Product Quantity12 units

Reason for Recall

Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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