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Creatinine plus ver.2

Roche Diagnostics GmbH · Model 08057524190 · UDI-DI 07613336121160

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510(k) clearances

563

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2020-07-13	Ortho-Clinical Diagnostics	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-08-15	Beckman Coulter Inc	It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti

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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.