Devices

Device Recall PrepStain Tecan USI

Model / Serial
Catalog Numbers - 799-13000-00 and 799-13000-00R
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Product Description
PrepStain Tecan US-I. || For use in the screening and detection of cervical cancer.
Manufacturer
Becton Dickinson & Co.
1 Event
- Recall of Device Recall PrepStain Tecan USI

Manufacturer

Becton Dickinson & Co.

Manufacturer Address
Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

One device with a similar name

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Device Recall PrepStain Tecan USII

Model / Serial
Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Product Description
PrepStain Tecan US-II. || For use in the screening and detection of cervical cancer.
Manufacturer
Becton Dickinson & Co.

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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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