Recall Z-2281-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2281-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-04

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-05-04, terminated 2021-09-20. It names one FDA 510(k) clearance: K131307. Product: Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.. Reason: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-05-04
Terminated: 2021-09-20
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATORSiemens Healthcare Diagnostics, Inc.·cleared 2014-01-24

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

Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.

Reason for recall

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

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