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Device Recall Tecan Genesis
Model / Serial
PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
Product Description
Tecan Clinical Workstations with Robonet software
Manufacturer
Tecan U S Inc
1 Event
Recall of Device Recall Tecan Genesis
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Manufacturer
Tecan U S Inc
Manufacturer Address
Tecan U S Inc, 4022 Stirrup Creek Rd,Ste310, Durham NC 27709
Source
USFDA
2 devices with a similar name
Learn more about the data
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Device Recall Tecan Genesis Instruments
Model / Serial
Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
Product Description
Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
Manufacturer
Tecan U S Inc
Device Recall Tecan Genesis
Model / Serial
Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
Product Description
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
Manufacturer
Roche Diagnostics Corp.
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