Dimension Magnesium (MG) Flex reagent cartridge recallZ-1816-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 17, 2022
Class II Open, Classified All recalls posted in September 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1816-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 17, 2022
- Posted by the FDA
- Sep 26, 2022
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 26851 units
- Product code
- JGJ
- FDA submissions
- K861700
- Distribution
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Product description
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Code information (models, lots, serial numbers)
Lot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840; MG lot FA2356 10444963 00842768014185FA235622122210444963840; MG lot GA2363 10444963 00842768014185GA236322122910444963840; MG lot FA3019 10444963 00842768014185FA301923011910444963840
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension® Flex® reagent cartridge MG 10444963Siemens Healthcare Diagnostics Inc. · PHOTOMETRIC METHOD, MAGNESIUM1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K861700 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Dimension® Flex® reagent cartridge ALB 10444975Siemens Healthcare Diagnostics Inc. · BROMCRESOL PURPLE DYE-BINDING, ALBUMIN6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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