Recall Z-1230-2015
Siemens Healthcare Diagnostics, Inc · initiated January 27, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Codes / lots: Lot Numbers: 42565268 42624268 43538268 Exp. Date: May 22, 2015
Reason for recall
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1230-2015
- Initiated
- January 27, 2015
- Posted by FDA
- March 2, 2015
- Terminated
- March 31, 2016
- Product code
- JLS – Radioimmunoassay, Progesterone
- Quantity
- 11980 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1229-2015 Class II | ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number:…ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL… | 01/27/2015Terminated |
| Z-1231-2015 Class II | ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog…ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL… | 01/27/2015Terminated |