FDA Device recall Z-1486-2018
ADVIA Centaur CA 125II Assay
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of ADVIA Centaur CA 125II Assay by Siemens Healthcare Diagnostics, citing upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1486-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-21 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Reason
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Identifiers
| code_info | SMN 10310443 (1-pack/100 tests): Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427 Lot 73…SMN 10310443 (1-pack/100 tests): Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427 Lot 73838174, Exp 2018-Apr-27, UDI (01)00630414461298(10)73838174(17)20180427 Lot 88601174, Exp 2018-Apr-27, UDI (01)00630414461298(10)88601174(17)20180427 Lot 94549174, Exp 2018-Apr-27, UDI (01)00630414461298(10)94549174(17)20180427 Lot 23904176, Exp 2018-Aug-30, UDI (01)00630414461298(10)23904176(17)20180830 Lot 24439176, Exp 2018-Aug-30, UDI (01)00630414461298(10)24439176(17)20180830 Lot 31842176, Exp 2018-Aug-30, UDI (01)00630414461298(10)31842176(17)20180830 Lot 42051176, Exp 2018-Aug-30, UDI (01)00630414461298(10)42051176(17)20180830 Lot 54008176, Exp 2018-Aug-30, UDI (01)00630414461298(10)54008176(17)20180830 SMN 10315696 (5-pack/500 tests): Lot 71229174, Exp 2018-Apr-27, UDI (01)00630414461304(10)71229174(17)20180427 Lot 73455174, Exp 2018-Apr-27, UDI (01)00630414461304(10)73455174(17)20180427 Lot 84113174, Exp 2018-Apr-27, UDI (01)00630414461304(10)8411 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1486-2018%22
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