Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge.… recallZ-2177-2011 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 10, 2010
Terminated All recalls posted in May 2011
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
Patient results may be falsely depressed or falsely elevated across the assay range.
FDA root cause category: Device Design
What the company is doing
Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit.
Recall details
- Recall number
- Z-2177-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 10, 2010
- Posted by the FDA
- May 10, 2011
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 860
- Product code
- JFY
- FDA submissions
- K073055
- Distribution
- Nationwide distribution.
Product description
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.
Code information (models, lots, serial numbers)
Catalog number DF270B - Lot numbers BD1008, CD1050, FA1081 and GA1190.
Other devices under the same FDA submission
1 device cleared under K073055 — 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® Flex® reagent cartridge EZCR 10471520Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall1 report
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.
How recalls are matched to devices · Editorial policy · Report an error on this page