Dimension clinical chemistry system — Class II medical device recall Z-1633-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-05-18, distributed in AR, CA, DC, FL, GA, IL, LA, MD…. Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one
| Recall number | Z-1633-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-02-09 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2018-06-12 |
| Distributed | AR, CA, DC, FL, GA, IL, LA, MD, MI, PR, TX, WI |
| Quantity | 394 |
| Reason classes | specification failure |
| Lot numbers | EB6064 |
Product
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Reason for recall
Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
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-1633-2016. 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.