Z-2741-2015Class II

Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension...

Name: Z-2741-2015 Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-07-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-15 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic... on 2015-07-15. FDA classified it as Class II and gives the reason as "Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2741-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-15
Posted: 2015-09-05
Terminated: 2017-03-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Medical Device Correction letter, dated July 2015, was provided to all Dimension CREA and Dimension Vista CREA customers who received the products to notify them of the issue, the potential risk to health, and actions to be taken by customers. If you have any questions please contact your Siemens Customer Care Center Technical Solutions at (800) 441-9250, or your local Siemens Technical Support Representative.
Quantity in commerce: Total number Dimension Vista - 32,165, Dimension - 238,634
Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia Herzegovinia, Bulgaria, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Great Britain, Greece, Guatemala, Hungary, Iraq, Ireland, Honduras, Hong Kong, Iceland, Indonesia, India, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Libya, Macedonia, Malaysia, Mali, Mexico, Myanmar, Morocco, Netherlands, Nepal, Nicaragua, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Uruguay, Venezuela, Vietnam and Yemen.
Product codes and lots: Dimension CREA Lot Numbers: DB5195 FA5211 EA5233 DA5258 FA5275 BA5293 EA5315 EA5316 GA5342 FA5351 FA5352 FA6006 BA6026 BA6027 EB6047 GB6076 GA6097 BA6111 BA6112 FB6139 with expiration dates: 2015-07-14 2015-07-30 2015-08-21 2015-09-15 2015-10-02 2015-10-20 2015-11-11 2015-11-12 2015-12-08 2015-12-17 2015-12-18 2016-01-06 2016-01-26 2016-01-27 2016-02-16 2016-03-16 2016-04-06 2016-04-20 2016-04-21 2016-05-20 Dimension Vista CREA Lot Numbers: 14177BB 14212BD 14234BH 14261BC 14280BA 14301BB 14321AC 14346AC 15012AA 15042BA 15054AB 15076BA 15091BA 15125BB 15125BA 15141AA with expiration dates: 2015-06-26 2015-07-31 2015-08-22 2015-09-18 2015-10-07 2015-10-28 2015-11-17 2015-12-12 2016-01-12 2016-02-11 2016-02-23 2016-03-16 2016-03-31 2016-05-04 2016-05-04 2016-05-22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2741-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2741-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-05

Product code JFY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)