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Colorimetry, Acetaminophen
FDA product code LDP · Class 2 · Clinical Toxicology
27
Registered devices
43
Adverse events
12
Recalls
37
510(k) clearances
Devices with this code
ACE — RANDOX LABORATORIES LIMITEDACETAMINOPHEN L3K — SEKISUI DIAGNOSTICS, LLCSynchron — Beckman Coulter, Inc.Dimension® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics Inc.Triage — QUIDEL CARDIOVASCULAR INC.ARCHITECT — ABBOTT LABORATORIESAlere Triage® — Alere San Diego, Inc.Triage — QUIDEL CARDIOVASCULAR INC.ONLINE TDM Acetaminophen Gen.2 — Roche Diagnostics GmbHAcetaminophen Liquicolor® — STANBIO LABORATORY, L.P.Alinity c Acetaminophen — SEKISUI DIAGNOSTICS, LLCAcetaminophen L3K Assay — SEKISUI DIAGNOSTICS, LLCAcetaminophen — Roche Diagnostics GmbHDRI Acetaminophen Serum Tox Assay — Microgenics CorporationDimension Vista® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics Inc.Alere Triage® — Alere San Diego, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Atellica CH Acet — Siemens Healthcare Diagnostics Inc.ONLINE TDM Acetaminophen Gen2 — Roche Diagnostics GmbHADVIA® Chemistry ACET Acetaminophen Reagents — Siemens Healthcare Diagnostics Inc.Syva® Emit® tox™ Acetaminophen Assay — Siemens Healthcare Diagnostics Inc.Emit® tox™ Acetaminophen Assay — Siemens Healthcare Diagnostics Inc.Acetaminophen Assay — SEKISUI DIAGNOSTICS, LLCAcetaminophen — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-02 | Roche Diagnostics Corporation | The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are mis |
| 2017-07-20 | Beckman Coulter Inc. | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision spec |
| 2016-01-22 | Sekisui Diagnostics P.E.I. Inc. | Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover |
| 2015-06-30 | Siemens Healthcare Diagnostics, Inc. | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-07-12 | Alere San Diego, Inc. | Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AM |
| 2012-05-29 | Sekisui Diagnostics Llc | Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. |
| 2010-12-07 | Roche Diagnostics Operations, Inc. | The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has |
| 2010-12-07 | Roche Diagnostics Operations, Inc. | The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has |
| 2008-07-10 | Beckman Coulter Inc | This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated he |
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