Dimension Magnesium — Class II medical device recall Z-1816-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-10-05, distributed in GA. Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and prod
| Recall number | Z-1816-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2022-08-17 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Distributed | GA |
| Countries outside the US | AE, AF, AT, BG, BH, CA, CH, CZ, DE, EG, ES, FR, GR, HR, HU, IL, IT, JO, KE, KW, LB, LV, MA, MT, NL, NP, PK, PL, PT, QA, RO, RS, SI, SK, TR, UA |
| Quantity | 26,851 units |
| UPC / GTIN / UDI-DI | 00842768014185 |
| Lot numbers | 10444963, FA2350, FA2356, FA3019, GA2363 |
Product
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1816-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.