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Terminated

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.

FDA Recall Z-2741-2015 · Posted 2015-09-05

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2015-07-15
Date Terminated2017-03-24
Product QuantityTotal number Dimension Vista - 32,165, Dimension - 238,634

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061238DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGEDade Behring, Inc. · 2006-05-25K925668CREATININE METH FOR USE ON THE DIMENSION CLIN CHEME.I. Dupont DE Nemours & Co., Inc. · 1992-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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