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Enzyme Immunoassay, Valproic Acid
FDA product code LEG · Class 2 · Clinical Toxicology
23
Registered devices
339
Adverse events
7
Recalls
35
510(k) clearances
Devices with this code
ARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Synchron — Beckman Coulter, Inc.Valproic Acid ONLINE TDM Valproic Acid — Roche Diagnostics GmbHIMMULITE® 2000 Systems VAL Valproic Acid — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDEmit® 2000 Valproic Acid — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge VALP — Siemens Healthcare Diagnostics Inc.Valproic Acid — Roche Diagnostics GmbHValproic Acid — Roche Diagnostics GmbHAtellica CH VPA — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems VAL Valproic Acid — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDFree Valproic Acid Controls — Roche Diagnostics GmbHVPA — RANDOX LABORATORIES LIMITEDADVIA® Chemistry VPA_2 Valproic Acid_2 Reagents — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT LABORATORIESSyva® Emit® 2000 Valproic Acid Assay — Siemens Healthcare Diagnostics Inc.Valproic Acid — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESCEDIA Valproic Acid II Assay — Microgenics CorporationValproic Acid — Roche Diagnostics GmbHValproic Acid — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge VALP — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-11 | Ortho-Clinical Diagnostics | Negative bias results when using VITROS VALP Reagent, GEN 25. |
| 2011-05-10 | Ortho-Clinical Diagnostics | Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affect |
| 2007-04-30 | Roche Diagnostics Corp. | Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: C |
| 2006-09-08 | Bayer Healthcare, LLC (Diagnostics Division) | 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 |
| 2006-09-08 | Bayer Healthcare, LLC (Diagnostics Division) | 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 |
| 2006-09-08 | Bayer Healthcare, LLC (Diagnostics Division) | 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 |
| 2005-04-18 | Ortho-Clinical Diagnostics | Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days. |
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