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Drug Mixture Control Materials
FDA product code DIF · Class 1 · Clinical Toxicology
617
Registered devices
6
Adverse events
10
Recalls
202
510(k) clearances
Devices with this code
DETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCAlere — BIOCHEMICAL DIAGNOSTICS INCDetectabuse — BIOCHEMICAL DIAGNOSTICS INCTriage — QUIDEL CARDIOVASCULAR INC.DETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCMulti-Analyte DAU Control Set D, Level 1 Control — LIN-ZHI INTERNATIONAL, INC.DETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCCARDINAL HEALTH — Cardinal Health 200, LLCDetectabuse — BIOCHEMICAL DIAGNOSTICS INCLead Level 3 — UTAK LABORATORIES, INC.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.DETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCDetectabuse — BIOCHEMICAL DIAGNOSTICS INCiScreen — BIOCHEMICAL DIAGNOSTICS INCDetectabuse — BIOCHEMICAL DIAGNOSTICS INCSALIVABUSE — BIOCHEMICAL DIAGNOSTICS INCLiquichek — BIO-RAD LABORATORIES, INC.DETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCFIRST SIGN® — HEMOSURE INC.Detectabuse — BIOCHEMICAL DIAGNOSTICS INCDETECTABUSE — BIOCHEMICAL DIAGNOSTICS INCMulti-Analyte DAU Control Set C, Level 1 Control — LIN-ZHI INTERNATIONAL, INC.Detectabuse — BIOCHEMICAL DIAGNOSTICS INCTriage — QUIDEL CARDIOVASCULAR INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-30 | MEDLINE INDUSTRIES, LP - Northfield | Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. |
| 2019-04-09 | QUIDEL CARDIOVASCULAR INC | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue resu |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BE |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BE |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BE |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BE |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BE |
| 2013-09-23 | Alere San Diego, Inc. | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with |
| 2011-08-05 | Lin-Zhi International Inc | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Le |
| 2005-06-27 | Abbott Laboratories MPG | The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay. |
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