Devices

Device Recall Xmatrx FISH

Model / Serial
Serial Numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, and AS40237
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
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 Description
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.
Manufacturer
Biogenex Laboratories
1 Event
- Recall of Device Recall Xmatrx FISH

Manufacturer

Biogenex Laboratories

Manufacturer Address
Biogenex Laboratories, 4600 Norris Canyon Road, San Ramon CA 94583-1320
Source
USFDA

One device with a similar name

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Device Recall Xmatrx FISH Automated Staining System

Model / Serial
Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Product was distributed to a single distributor, which further distributed the product.
Product Description
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
Manufacturer
Biogenex Laboratories

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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