Dimension — Class II medical device recall Z-0561-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-01-01, distributed nationwide. Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shif
| Recall number | Z-0561-2014 |
|---|---|
| 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 | 2013-05-06 |
| Classified | 2013-12-23 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 17,719 |
| Lot numbers | RD23031, RD23111, RD23241, RD23311, RD23461 |
| Expiration dates | 2013-04-29, 2013-05-07, 2013-05-19, 2013-06-04, 2013-06-11 |
Product
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Reason for recall
Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
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-0561-2014. 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.