Recall Z-0831-2020 · CGN Acid, Folic, Radioimmunoassay
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
| Date | Jan 21, 2020 (initiated Jul 22, 2019) |
| Status | Terminated |
| Reason | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| Root cause | Device Design |
| Action | Siemens issued Urgent Medical Device Correction, CC 19-07.A.US to customers on July 22, 2019 to be delivered to customers on July 23, 2019. After release of the letter (CC 19-07.A.US), we identified a typographical error in Table 1, specifically the Reference kit SMN (19331250). Version B (CC 19-07-B.US) is being created with the corrected SMN Number (10331250) and distributed to the reference accounts that order SMN (Quest Diagnostics). Urgent Field Safety Notice, CC 19-07.A.OUS was sent out to the country organizations on July 19, 2019 for distribution to customers outside the United State |
| Quantity | 3,627 kits |
| Distribution | Nationwide Foreign: Armenia¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿ |
| 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 |