FDA Device recall Z-0134-2021
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of al…
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of al… by Siemens Healthcare Diagnostics, citing low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentratio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0134-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-25 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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
Identifiers
| code_info | Lot Number/UDI/Exp. Date: 1) 19247AB UDI: 0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.