Recall Z-2416-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2416-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-06-30, terminated 2016-09-01. It names one FDA 510(k) clearance: K100200. Product: ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.. Reason: A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Terminated: 2016-09-01
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare Diagnostics·cleared 2010-08-02

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

ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.

Reason for recall

A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.

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