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Salicyclate

Roche Diagnostics GmbH · Model 08058636190 · UDI-DI 07613336121504

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-04-03	Beckman Coulter Inc.	Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results
2016-07-25	Microgenics Corporation	Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
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.
2007-10-22	Beckman Coulter Inc	The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.
2006-12-05	Diagnostic Chemicals, Ltd.	Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the produc

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Data 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.