Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine)
Medical device recall Z-2741-2015. Published in FDA’s Enforcement Report on Sep 16, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 16, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- Total number Dimension Vista - 32,165, Dimension - 238,634 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
Total number Dimension Vista - 32,165, Dimension - 238,634, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 771 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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 15, 2015.
- FDA classified it on Sep 5, 2015.
- FDA’s Enforcement Report published it on Sep 16, 2015.
- FDA terminated it on Mar 24, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Healthcare Diagnostics, Inc., of Newark, DE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.