Reported Oct 5, 2022 · Ongoing
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
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?
- Dimension Magnesium (MG) Flex reagent cartridge Siemens Material
- Number (SMN)/REF (Catalog Number)10444963/DF57
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840 2 MG lot FA2356 10444963 00842768014185FA235622122210444963840 3 MG lot GA2363 10444963 00842768014185GA236322122910444963840 4 MG lot FA3019 10444963 00842768014185FA301923011910444963840 - Amount recalled
- 26851 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur
This product could cause temporary or reversible health problems — stop using it.
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