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ONLINE TDM Acetaminophen Gen.2
Roche Diagnostics GmbH · Model 08056684190 · UDI-DI 07613336120934
LDP
Prescription
1
510(k) clearances
43
Adverse events
12
Recalls
20
Facilities
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 missing the following s |
| 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 specification. |
| 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: AMP, BAR, and PCP, the |
| 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 been performed to q |
| 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 been performed to q |
| 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 heparin has shown a ne |
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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.