Siemens Healthcare Diagnostics, Inc. Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog number KC130. Lot number 9ED058 exp 5/1/10
Products Sold
Catalog number KC130. Lot number 9ED058 exp 5/1/10
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia due to patient results are depressed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
patient results are depressed
Recommended Action
Per FDA guidance
An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026