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Class 2 Device Recall Dimension Vista Enzymatic Creatinine (ECREA) |
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Date Initiated by Firm |
May 04, 2020 |
Date Posted |
June 05, 2020 |
Recall Status1 |
Terminated 3 on September 20, 2021 |
Recall Number |
Z-2285-2020 |
Recall Event ID |
85602 |
510(K)Number |
K090330
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Product Classification |
Enzymatic method, creatinine - Product Code JFY
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Product |
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease. |
Code Information |
Lot #s 20027AC, 19336AA, 19273AA, 19218AB, 19192AB, 19189AA, 19175AA, ***Updated 8/4/20*** 20083AA ***Updated 11/2/20*** 20128AB 20202AA |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Newark DE 19702-2466
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For Additional Information Contact |
Aarti Aziz 914-656-9027
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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.
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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 |
23,824 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JFY and Original Applicant = Siemens Healthcare Diagnostics Inc.
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