—#89007

Product

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.

FDA product code: JFY — Enzymatic Method, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K090330
Affected lot / code info: Catalog number K1270. Lot number 09224AA

Why it was recalled

The ECREA test results may be falsely elevated or depressed.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-02-12
Posted by FDA: 2010-09-16
Terminated: 2010-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.