—#183697

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

FDA product code: CJO — Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K122323
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-08-25
Posted by FDA: 2020-10-20
Terminated: 2023-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183697. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.