Siemens Dimension Chemistry Wash — Class II medical device recall Z-2238-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-08-27, distributed nationwide. Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and pati
| Recall number | Z-2238-2014 |
|---|---|
| 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 | 2014-07-15 |
| Classified | 2014-08-15 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,200 |
| Lot numbers | RD41041 |
| Expiration dates | 2014-10-13 |
Product
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
Reason for recall
Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv
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-2238-2014. 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.