Z-0134-2021Class II

Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the...

Name: Z-0134-2021 Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-08-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-08-25 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase... on 2020-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0134-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-25
Posted: 2020-10-20
Terminated: 2023-05-04
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
Product code: CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
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 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0134-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20

Product code CJO

K122323Class IIDimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (AlpiSiemens Healthcare Diagnostics / cleared 2012-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)