Siemens Dimension — Class II medical device recall Z-1049-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-04-10, distributed nationwide. Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent du
| Recall number | Z-1049-2013 |
|---|---|
| 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 | 2013-02-22 |
| Classified | 2013-04-02 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 60,674 |
| Lot numbers | BB3152, BB3190, BC3127, CB4014, DA3092, DA3212, DA3319, DA3320, DC3078, EA3233, EC3166, FB3109, FB3260, FB3346, FB4029, GC3337 |
| Expiration dates | 2013-03-19, 2013-04-02, 2013-04-19, 2013-05-07, 2013-06-01, 2013-06-15, 2013-07-09, 2013-07-31, 2013-08-21, 2013-09-17, 2013-11-15, 2013-11-16, 2013-12-03, 2013-12-12, 2014-01-14, 2014-01-29 |
Product
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
Reason for recall
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
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-1049-2013. 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.