FDA Device recall Z-1816-2022
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57 by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1816-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-17 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
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
Identifiers
| code_info | Lot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840; MG lot FA2356 10444963 0084276801…Lot Number: UDI MG lot FA2350 10444963 00842768014185FA235022121610444963840; MG lot FA2356 10444963 00842768014185FA235622122210444963840; MG lot GA2363 10444963 00842768014185GA236322122910444963840; MG lot FA3019 10444963 00842768014185FA301923011910444963840 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1816-2022%22
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