FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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
- Recall number
- Z-0134-2021
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2020-08-25
- Posted
- 2020-10-20
- Terminated
- 2023-05-04
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K122323"]
- PMA numbers
- not on file
- Product code
- CJO
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28