—#99241

Product

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.

FDA product code: JFY — Enzymatic Method, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K073055
Affected lot / code info: Catalog number DF270B - Lot numbers BD1008, CD1050, FA1081 and GA1190.

Why it was recalled

Patient results may be falsely depressed or falsely elevated across the assay range.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2010-06-10
Posted by FDA: 2011-05-10
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.