Enzyme Immunoassay, Valproic Acid
Clinical Toxicology · 21 CFR 862.3645
Recent MDR events
339 adverse event reports on file
- VITROS Chemistry Products VALP ReagentJul 31, 2026MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2026-00044
- VITROS Chemistry Products VALP ReagentJul 31, 2026MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2026-00046
- VITROS CHEMISTRY PRODUCTS VALP REAGENTMay 28, 2026MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2026-00026
- VITROS CHEMISTRY PRODUCTS VALP REAGENTMay 28, 2026MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2026-00027
- ONLINE TDM VALPROIC ACIDMay 20, 2026MalfunctionRoche Diagnostics1823260-2026-01989
- ONLINE TDM VALPROIC ACIDNov 3, 2025MalfunctionRoche Diagnostics1823260-2025-04462
- VITROS CHEMISTRY PRODUCTS VALP REAGENTAug 28, 2025MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2025-00029
- VITROS CHEMISTRY PRODUCTS VALP REAGENTJun 4, 2025MalfunctionOrtho-clinical Diagnostics, Inc.1319808-2025-00023
- ONLINE TDM VALPROIC ACIDMay 6, 2025MalfunctionRoche Diagnostics1823260-2025-01388
- ONLINE TDM VALPROIC ACIDApr 9, 2025MalfunctionRoche Diagnostics1823260-2025-01079
Event type breakdown
Recalls
7 recall events for this product code
- Ortho-Clinical DiagnosticsTerminatedFeb 8, 2012
VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK
Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.
Z-0984-2012 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedJun 9, 2007
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
Z-0920-2007 · View FDA record ↗ - Bayer Healthcare, LLC (Diagnostics Division)TerminatedJan 17, 2007
ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are wi
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.
Z-0351-2007 · View FDA record ↗ - Bayer Healthcare, LLC (Diagnostics Division)TerminatedJan 17, 2007
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.
Z-0352-2007 · View FDA record ↗ - Bayer Healthcare, LLC (Diagnostics Division)TerminatedJan 17, 2007
ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are wi
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.
Z-0353-2007 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedJun 4, 2005
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical
Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
Z-0866-05 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only.
Negative bias results when using VITROS VALP Reagent, GEN 25.
Z-0848-2019 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Diamond Diagnostics Inc.
Budapest, HU
Beckman Coulter, Inc.
BREA, CA, US
Microgenics Corporation
Fremont, CA, US
Abbott Laboratories
Lake Forest, IL, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Ortho Clinical Diagnostics
Singapore South West, SG
B.r.a.h.m.s Gmbh
HENNIGSDORF Brandenburg, DE
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
510(k) clearances
35 clearances for this product code
- Abbott Laboratories, Inc.Aug 6, 2009
K090358 · ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
- Roche Diagnostics Corp.Aug 8, 2006
K060690 · ONLINE VALPROIC ACID
- Bayer Healthcare, LLCFeb 8, 2005
K042807 · ADVIA IMS VALPROIC ACID METHOD
- Ortho-Clinical Diagnostics, Inc.Dec 1, 2004
K042476 · VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
- Roche Diagnostics Corp.Aug 22, 2003
K032049 · ROCHE ONLINE TDM VALPROIC ACID
- Beckman Coulter, Inc.Jul 15, 2003
K031870 · SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
- SeradynApr 28, 2003
K030405 · QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
- Randox Laboratories, Ltd.Jan 15, 2002
K011649 · RANDOX VALPROIC ACID