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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Enzymatic Creatinine (ECREA) reagent

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  Class 2 Device Recall Dimension Vista Enzymatic Creatinine (ECREA) reagent see related information
Date Initiated by Firm December 18, 2019
Date Posted January 24, 2020
Recall Status1 Terminated 3 on June 25, 2020
Recall Number Z-1233-2020
Recall Event ID 84612
510(K)Number K090330  
Product Classification Enzymatic method, creatinine - Product Code JFY
Product Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Code Information UDI Number: 00842768036262 Lots: All lots
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		 There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Quantity in Commerce 11,725 units
Distribution US Nationwide
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 = JFY and Original Applicant = Siemens Healthcare Diagnostics Inc.
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