FDA Device recall Z-1153-2023
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cel…
- FDA Device
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cel… by Siemens Healthcare Diagnostics, citing negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1153-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-09 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
Reason
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Identifiers
| code_info | UDI: (01)00630414450940(10)16276336 (17)20230320; (01)00630414450940(10)21334336(17)20230320; (01)006304…UDI: (01)00630414450940(10)16276336 (17)20230320; (01)00630414450940(10)21334336(17)20230320; (01)00630414450940(10)22079336(17)20230320; (01)00630414450940(10)27946338(17)20230529; (01)00630414450940(10)41225342(17)20230630; (01)00630414450940(10)62966344 (17)20230726; Lot Numbers: 16276336, 21334336, 22079336, 27946338, 41225342, 62966344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1153-2023%22
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