Recall Z-1422-2020— Beckman Coulter Inc

Name: FDA recall Z-1422-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-15

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc, initiated 2019-08-15, terminated 2024-02-28. It names one FDA 510(k) clearance: K091742. Product: Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733. Reason: 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 quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment..

Recalling firm: Beckman Coulter Inc
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Terminated: 2024-02-28
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K091742 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298Beckman Coulter, Inc.·cleared 2009-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733

Reason for recall

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 quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.