Dimension Vista ECREA Flex Reagent Cartridge recallZ-2419-2010 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 12, 2010
Terminated All recalls posted in September 2010
Is my device affected?
- 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.
- 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.
- 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
The ECREA test results may be falsely elevated or depressed.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens sent an Urgent Field Safety Notice dated February 2010 to all affected customers. The letter described the product, the problem, and the action to be taken by the customers. The customers were instructed to immediately discontinue the use of and discard the ECREA Flex reagent cartridge lot 09224AA. Customers are to contact their Siemens Customer Service Center at 800-241-0420 to report their additional no-charge replacement needs, and complete and return the enclosed Field Correction Effectiveness Check Form via Fax at 302-631-8467. For any technical questions regarding this Recall contact Siemens Technical Solutions Center at 800-441-9250.
Recall details
- Recall number
- Z-2419-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 12, 2010
- Posted by the FDA
- Sep 16, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 324
- Product code
- JFY
- FDA submissions
- K090330
- Distribution
- Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands.
Product description
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes.
Code information (models, lots, serial numbers)
Catalog number K1270. Lot number 09224AA
Other devices under the same FDA submission
1 device cleared under K090330 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® Flex® reagent cartridge ECREA 10700444Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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