Siemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
Siemens Healthcare Diagnostics is recalling Alkaline Phosphatase (ALPI) Flex reagent cartridges due to low outlier test results. The recall covers 5,970 US units and 1,446 international units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (low outliers) which poses a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Alkaline Phosphatase (ALPI) Flex reagent cartridge, an in vitro diagnostic test used for the quantitative measurement of alkaline phosphatase in human serum and plasma. The recall is due to the generation of low outlier results. The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). These low outlier results are generated from the last five (5) tests of the well.
The recall affects 5,970 units in the United States and 1,446 units outside the US. Distribution was worldwide, including the US, Canada, Australia, Austria, Belgium, the Bahamas, the Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, the Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, and Switzerland. Affected lot numbers include 19247AB, 19282BB, and 19330BD, as well as expanded recall lots 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, and 20078AB.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- (2) 19282BB UDI: 0084276803903419282BB20100810642444840 Exp. 2020-10-08
- 20311BA
- 20275AA
- 20218AA
- 20203BA
- 20170AA
- 20125BA
- 20078AB.
Distribution
Distributed nationwide across the United States.
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