Class 2 Device Recall Dimension Vista Alkaline Phosphatase (ALPI) Flex reagent cartridge

• Date Initiated by Firm: August 25, 2020
• Date Posted: October 20, 2020
• Recall Status: Terminated on May 04, 2023
• Recall Number: Z-0134-2021
• Recall Event ID: 86430
• 510(K)Number: K122323
• Product Classification: Alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes - Product Code CJO
• Product: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma; ; Catalog Number: K2115, SMN# 10642444
• Code Information: Lot Number/UDI/Exp. Date: 1) 19247AB UDI: 0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB UDI: 0084276803903419282BB20100810642444840 Exp. 2020-10-08, (3) 19330BD UDI:0084276803903419330BD20112510642444840 Exp. 2020-11-25. Expanded Recall: 3/10/21 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr; Newark DE 19702-2466
• For Additional Information Contact: SAME; 800-441-9250
• Manufacturer Reason for Recall: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens issued Urgent Medical Device Recall (UMDC # VC-20-02.A.US via Fed'X) and Urgent Field Safety Notice (UFSN # VC-20-02.A.OUS) on August 25, 2020 to all Dimension Vista customers who received the Dimension Vista ALPI flex reagent lots 19247AB, 19282BB and 19330BD to notify them of the issue, health risk and actions to take. Customers were instructed to: Discontinue use of and discard the Dimension Vista ALPI lots 19247AB, 19282BB, 19330BD. Review their inventory of these lots to determine their laboratorys replacement needs. Complete and return the attached form to this letter to request your no-charge replacement product(s). Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. If they received any complaints of illness or adverse events associated with the product listed in the letter, to immediately contact their local Siemens Remote Services Center or their local Siemens Technical Support Representative. Expanded Recall 3/12/21: Urgent Medical Device Correction (UMDC # VC-20-02.B.US) and Urgent Field Safety Notice (UFSN # VC-20-02.B.OUS) issued on March 12, 2021 to all Dimension Vista customers who received the Dimension Vista ALPI flex reagent lots 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA and 20078AB to notify them of the issue, and actions to be taken.
• Quantity in Commerce: US:5970 units ; OUS: 1446 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Belgium, Bahamas, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, Switzerland.
• 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 = CJO and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS