Devices

Device Recall VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished

Model / Serial
VITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297, 34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
Product Description
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. || Intended for use in the measurement of a variety of chemistry analytes.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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