Recall Z-1255-2017
Siemens Healthcare Diagnostics, Inc · initiated January 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Codes / lots: Lot Numbers: 07996A90 21172A90 27221A90 44366A90 63785A90 Exp. Date: 2017/07/24
Reason for recall
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Siemens issued Urgent Medical Device Recall (UMDR) sent to Siemens Healthcare Diagnostics customers in the United States on January 10, 2017 to be delivered to customers on January 11, 2017. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on January 10, 2017. The customer distribution included all customers that have received ADVIA Centaur Systems Calibrator A kit lots ending in 90 and ADVIA Centaur FT4 ReadyPacks. These notices inform the customer a negative bias has been confirmed for the ADVIA Centaur FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. ADVIA Centaur FT4 assay customers using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems were directed to discontinue the use of Calibrator A kit lots ending in 90 and instead use Calibrator A kit lots ending in 91 and above to calibrate the FT4 assay.
Details
- Recall number
- Z-1255-2017
- Initiated
- January 10, 2017
- Terminated
- July 16, 2019
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 1937 kits
- Distribution
- Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1254-2017 Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator… | 01/10/2017Terminated |
| Z-1256-2017 Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator… | 01/10/2017Terminated |