Reported Oct 28, 2020 · Terminated
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466
Is this the product you have?
- 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
K2115SMN# 10642444
- Lot codes and dates
- Lot Number/UDI/Exp
- Date1) 19247AB
- UDI0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB
- UDI0084276803903419282BB20100810642444840 Exp. 2020-10-08, (3) 19330BD
- UDI0084276803903419330BD20112510642444840 Exp. 2020-11-25
- Expanded Recall
3/10/21 20337AB20311BA20275AA20218AA20203BA20170AA20125BA20078AB
- Amount recalled
- US:5970 units ; OUS: 1446 units
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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