Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemis
FDA device recall Z-2741-2015 · posted 2015-09-05 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 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, Bu
- Date initiated
- 2015-07-15
- Date posted
- 2015-09-05
- Date terminated
- 2017-03-24
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE (K061238) | Dade Behring, Inc. | 2006-05-25 |
| CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM (K925668) | E.I. Dupont DE Nemours & Co., Inc. | 1992-12-28 |