FDA Device recall Z-1015-2022
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog num…
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog num… by Siemens Healthcare Diagnostics, citing potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1015-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-22 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Reason
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Identifiers
| code_info | 8 production lots: 463, 464, 466, 467, 469, 470, 471, 472, [UDI for 200 tests: (01)00630414961132(10)463(17)20220228, (…8 production lots: 463, 464, 466, 467, 469, 470, 471, 472, [UDI for 200 tests: (01)00630414961132(10)463(17)20220228, (01)00630414961132(10)464(17)20220331, (01)00630414961132(10)466(17)20220331, (01)00630414961132(10)467(17)20220531, (01)00630414961132(10)469(17)20220731, (01)00630414961132(10)470(17)20220930, (01)00630414961132(10)471(17)20221130, (01)00630414961132(10)472(17)20230228] [UDI for 600 tests: (01)00630414961149(10)463(17)20220228, 01)00630414961149(10)464(17)20220331, (01)00630414961149(10)466(17)20220331, (01)00630414961149(10)467(17)20220531, (01)00630414961149(10)469(17)20220731, (01)00630414961149(10)470(17)20220930, (01)00630414961149(10)471(17)20221130, (01)00630414961149(10)472(17)20230228] |
|---|
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-1015-2022%22
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