FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
- Recall number
- Z-1970-2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
- Status
- Terminated
- Initiated
- 2013-06-28
- Posted
- 2013-08-14
- Terminated
- 2014-07-25
- Reason
- Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Medical Device Correction (UDMC) was sent to all affected Siemens Healthcare Diagnostic customers in the United States on June 28, 2013 via FedEx. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 27, 2013. FedEx Return Receipts will be used to confirm that the customers received the UMDC. If confirmation of receipt by any customer cannot be verified through a return receipt, a Siemens Technical Solutions Center Representative will contact those customers by telephone to ensure that they received the Urgent Medical Device Correction and completed the required actions. These notices inform the customer that they should discontinue the use of Calibrator A, lots ending in 77, for use with the ADVIA Centaur Systems T4 assay. Customers are informed that they may continue to use Calibrator A lot CA77 with the other assays FT3, FT4, Total T3, T-Uptake. For questions or additional information contact your local Technical Support Provider or Distributor.
- Quantity
- 265 Cal A 6 packs (US and OUS)
- Distribution
- Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA.
- Lot, serial or model codes
- REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013
- 510(k) numbers
- ["K961510"]
- PMA numbers
- not on file
- Product code
- JIS
- 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