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Afinion ACR

Abbott Diagnostics Technologies AS · Model 1116972 · UDI-DI 07070060014630

JFY Prescription
10
510(k) clearances
563
Adverse events
29
Recalls
52
Facilities

Description

Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert.

Recalls

DateFirmReason
2020-07-13Ortho-Clinical DiagnosticsEtrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-08-15Beckman Coulter IncIt 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.