VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 68...
FDA Recall #Z-0848-2019 — Class II — December 11, 2018
Product Description
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Reason for Recall
Negative bias results when using VITROS VALP Reagent, GEN 25.
Recalling Firm
Ortho-Clinical Diagnostics — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9014 Total (U.S. = 6798; OUS: U.S. = 2216)
Distribution
Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
Code Information
Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.