International Medical Devices Database

Manufacturer Address
Remel, Inc., 12076 Santa Fe Trail Dr, (PO Box 14478, zip 66285-4478), Lenexa KS 66215-3519
Source
USFDA
7 Events

7 devices in the database

Device Recall ProSpecT Campylobacter Microplate Assay

Model / Serial
Lot #910718
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Entire lot was shipped to one customer in Russelsheim, Germany.
Product Description
ProSpecT Campylobacter Microplate Assay. Catalog #2476096.

Device Recall ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay

Model / Serial
918706 918707
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
US and OUS.
Product Description
ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.

Device Recall ProSpecT Giardia/Cryptosporidium Micorplate Assay.

Model / Serial
926230
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US only
Product Description
ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.

Device Recall ProSpecT Giardia/Cryptosporidium Microplate Assay.

Model / Serial
944755
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US and OUS customers.
Product Description
ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.

Device Recall ProSpecT Cryptosporidium Microplate Assay

Model / Serial
910717 912101
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
in the US
Product Description
ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.

2 more

3 manufacturers with a similar name

Learn more about the data here

Remel, Inc.

Manufacturer Address
Remel, Inc., 12076 Santa Fe Dr, Lenexa KS 66215
Source
USFDA

Remel, Inc.

Manufacturer Address
Remel, Inc., 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
Source
USFDA

Remel, Inc.

Manufacturer Address
Remel, Inc., 12076 Santa Fe Trail Dr, Lenexa KS 66215
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

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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