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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Fructosamine (FRUC) reagent

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  Class 2 Device Recall ADVIA Chemistry Fructosamine (FRUC) reagent see related information
Date Initiated by Firm May 04, 2020
Date Posted June 05, 2020
Recall Status1 Terminated 3 on September 20, 2021
Recall Number Z-2280-2020
Recall Event ID 85602
510(K)Number K131307  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: 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.
Code Information Lot # 501874
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact Aarti Aziz
914-656-9027
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 5
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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