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Colorimetry, Acetaminophen
FDA product code LDP · Class 2 · Clinical Toxicology
27
Registered devices
45
Adverse events
12
Recalls
37
510(k) clearances
Devices with this code
ARCHITECT — ABBOTT LABORATORIESSynchron — Beckman Coulter, Inc.Alere Triage® — Alere San Diego, Inc.Dimension® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics Inc.Atellica CH Acetaminophen (AcetC) — Siemens Healthcare Diagnostics Inc.Syva® Emit® tox™ Acetaminophen Assay — Siemens Healthcare Diagnostics Inc.ACE — RANDOX LABORATORIES LIMITEDTriage — QUIDEL CARDIOVASCULAR INC.Emit® tox™ Acetaminophen Assay — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry ACET Acetaminophen Reagents — Siemens Healthcare Diagnostics Inc.Alere Triage® — Alere San Diego, Inc.Acetaminophen Assay — Sekisui Diagnostics, LLCAcetaminophen — Roche Diagnostics GmbHAcetaminophen — Roche Diagnostics GmbHAcetaminophen Liquicolor® — STANBIO LABORATORY, L.P.ONLINE TDM Acetaminophen Gen2 — Roche Diagnostics GmbHACETAMINOPHEN L3K — Sekisui Diagnostics, LLCAcetaminophen L3K Assay — Sekisui Diagnostics, LLCDimension Vista® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics Inc.Alinity c Acetaminophen — Sekisui Diagnostics, LLCDRI Acetaminophen Serum Tox Calibrators — Microgenics CorporationDRI Acetaminophen Serum Tox Assay — Microgenics CorporationTriage — QUIDEL CARDIOVASCULAR INC.ACETAMINOPHEN L3K — Sekisui Diagnostics, LLC
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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