Devices

Device Recall VITROS Valproic Acid (VALP) Reagent

Model / Serial
Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12).
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product Description
VITROS¿ Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. || For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS Valproic Acid (VALP) Reagent

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
Source
USFDA

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