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Terminated

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.

FDA Recall Z-2281-2020 · Posted 2020-06-05

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLCP
Date Initiated2020-05-04
Date Terminated2021-09-20
Product Quantity26

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.

Firm Action

On May 4, 2020, Siemens notified their customers that use the Fructosamine and Enzymatic Creatinine assays on the Atellica, ADVIA, and Dimension platforms of the potential for falsely depressed results in the presence of NAPQI. An Urgent Medical Device Correction Notice was sent to consignees in the US and an Urgent Field Safety Notice was sent to customers outside the US. The letter stated that the Limitations of the Procedure section of the Instructions for Use (IFU) will be updated with specific information related to the assay/platform. Customers were asked to complete and return the Effectiveness Check questionnaire attached to the letter within 30 days. In addition, customers were informed that field service personnel will be sent an Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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