Recall Z-2739-2015 ยท CGN Acid, Folic, Radioimmunoassay
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
| Date | Sep 4, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay. |
| Root cause | Process design |
| Action | An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673 and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative |
| Quantity | 466 |
| Distribution | Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Bayer Diagnostics Corp., Feb 5, 2001 |