Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1816-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 17, 2022

Date Posted: October 5, 2022

Recall Number: Z-1816-2022

Event ID: 90825

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

Status: Ongoing

Product Quantity: 26851 units

Code Information:

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

Distribution Pattern:

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¿¿¿¿¿

Voluntary or Mandated:

Voluntary: Firm initiated