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Dimension CREA (Creatinine) and Dimension Vista CREA… recallZ-2741-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 15, 2015

Class II Terminated All recalls posted in September 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2741-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 15, 2015
Posted by the FDA
Sep 5, 2015
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
Total number Dimension Vista - 32,165, Dimension - 238,634
Product code
JFY
FDA submissions
K061238, K925668
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 description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

1 device cleared under K061238, K925668 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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