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

FDA device recall Z-1816-2022 · posted 2022-09-26 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JGJ

Quantity affected

26851 units

Distribution

Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Canada Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿

Date initiated

2022-08-17

Date posted

2022-09-26

Location

Newark, DE

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