—#96911

Product

Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.

FDA product code: CGX — Alkaline Picrate, Colorimetry, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K925668
Affected lot / code info: Catalog Number DF33A - Lots BB1286, CA1260 and FB1251

Why it was recalled

Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

The firm, SIEMENS, sent an "Urgent Field Safety Notice" dated December 2010 to all customers. The letter described the product ( Dimension(R) CREA Flex(R) Reagent Cartridges DF33A lots BB1286, CA1260 and FB1251), problem and actions to be taken. The customers were instructed to please discontinue use and discard any remaining inventory of the product; complete and return the fax form to the Customer Service Support for replacement of the product; if they must continue use of the product until they receive a replacement, open a new well set every 8 hours to minimize any impact to CREA test results, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the Technical Solution Center at 302-631-8467. If you have any questions, contact the Technical Solution 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: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.

Timeline

Recall initiated: 2010-12-27
Terminated: 2013-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.