—#133848

Product

ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.

FDA product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K932955
Affected lot / code info: Lot Numbers: 42590268 43742268 44847268 Exp. Date: May 22, 2015

Why it was recalled

ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

Root cause (FDA determination)

Process control

Action the firm took

Siemens issued an Urgent Medical Device Correction (UMDC) was sent to affected Siemens Healthcare Diagnostics customers in the United States on January 27, 2015 to be delivered to customers on January 28, 2015. An Urgent Field Safety Notice (U FSN) was sent out for distribution to all customers outside the United States on January 27, 2015. These notices inform the customer of the potential to observe a high bias on patient sample with results greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. To mitigate the bias, Siemens instructs customers to dilute samples with values greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. In addition, Siemens informs customers to continue to follow Urgent Medical Device Correction 10819675, Rev. A and Urgent Field Safety notice 10819674, Rev A (Information Regarding the ADVIA Centaur Systems Calibrator E), dated September 2014. Fax-back forms to be returned to confirm that the customers received the Urgent Medical Device Correction.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.

Timeline

Recall initiated: 2015-01-27
Posted by FDA: 2015-03-02
Terminated: 2016-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.