Devices

Device Recall VITROS Chemistry Products ACET Slides

Model / Serial
Multiple lots affected, with expiry dates through 22-Mar-2015
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
Product Description
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 || VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS Chemistry Products ACET Slides

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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