Siemens Healthcare Diagnostics, Inc.: Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57

Recall number

Z-1816-2022

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

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

Status

Open, Classified

Initiated

2022-08-17

Posted

2022-09-26

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

Siemens Healthineers issued to US Customers Urgent Medical Device Correction (VC-22-01.B.US) on 8/17/22 via Fed'X and OUS Customers sent Urgent Field Safety Notice (VC-22-01.B.OUS) to inform them to discontinue use and discard Dimension MG lots FA2350, FA2356, GA2363, and FA3019. Letter states reason for recall, health risk and action t take: Discontinue use and discard Dimension MG lots listed in Table 1. Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative

Quantity

26851 units

Distribution

Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Canada Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Kazakhstan¿¿¿¿¿ Kenya¿¿¿¿¿¿¿¿¿¿ Kuwait¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lebanon¿¿¿¿¿¿¿¿ Macedonia¿¿¿¿¿¿ Mali¿¿¿¿¿¿¿¿¿¿¿ Malta¿¿¿¿¿¿¿¿¿¿ Montenegro¿¿¿¿¿ Morocco¿¿¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Saudi¿Arabia¿¿¿ Senegal¿¿¿¿¿¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sudan¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ Uganda¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uzbekistan¿¿¿¿¿

Lot, serial or model codes

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

510(k) numbers

["K861700"]

PMA numbers

not on file

Product code

JGJ

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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