CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report

Dimension Magnesium (MG) Flex reagent cartridge Siemens recalled

Siemens Healthcare Diagnostics is recalling Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN), distributed in Georgia. The recall was initiated on 17 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840; MG lot FA2356 10444963 00842768014185FA235622122210444963840; MG lot GA2363 10444963 00842768014185GA236322122910444963840; MG lot FA3019 10444963 00842768014185FA301923011910444963840

Quantity recalled26851 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1816-2022
FDA event ID: 90825
Recalling firm: Siemens Healthcare Diagnostics, Newark, DE
Classification: Class II
Status: Ongoing
Recall initiated: 17 Aug 2022
FDA classified: 26 Sep 2022
Reported: 5 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

17 Aug 2022	Recall initiated by company
26 Sep 2022	Classified by FDA	+40 days
5 Oct 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57

Where it was distributed

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Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840; MG lot FA2356 10444963 00842768014185FA235622122210444963840; MG lot GA2363 10444963 00842768014185GA236322122910444963840; MG lot FA3019 10444963 00842768014185FA301923011910444963840

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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