Dimension Enzymatic Creatinine Flex reagent cartridge, DF270 recallZ-0485-2009 · Dade Behring, Inc. · initiated Sep 29, 2008
Terminated All recalls posted in December 2008
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 Dade Behring, 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
Reagent may exhibit unflagged inaccurate patient sample results.
FDA root cause category: Component design/selection
What the company is doing
The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.
Recall details
- Recall number
- Z-0485-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 29, 2008
- Posted by the FDA
- Dec 13, 2008
- Recalling firm
- Dade Behring, Inc.
- Quantity
- 12,773 cartons
- Product code
- JFY
- FDA submissions
- K073055
- Distribution
- Nationwide Distribution.
Product description
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry 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)
Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
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.
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