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IMMULITE®/IMMULITE® 1000 Systems VAL Valproic Acid
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10381509 · UDI-DI 00630414964850
1
510(k) clearances
339
Adverse events
7
Recalls
22
Facilities
Description
Valproic Acid - IMMULITE - RGT - 100 Tests
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 affected by this issue. |
| 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: Creatinine Kinase L a |
| 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 Drug (TDM) assays. |
| 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 Drug (TDM) assays. |
| 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 Drug (TDM) assays. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.