FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
- Recall number
- Z-1231-2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
- Status
- Terminated
- Initiated
- 2015-01-27
- Posted
- 2015-03-02
- Terminated
- 2016-03-31
- Reason
- 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
- Process control
- Action
- 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.
- Quantity
- 1719 kits
- Distribution
- 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.
- Lot, serial or model codes
- Lot Numbers: 42590268 43742268 44847268 Exp. Date: May 22, 2015
- 510(k) numbers
- ["K932955"]
- PMA numbers
- not on file
- Product code
- JLS
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28