Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-1015-2022

Z-1015-2022 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

FDA device recall Z-1015-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Feb 22, 2022 and is designated Class II. Reason for recall: Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. The recall status is ongoing. Affected quantity: 10,755 boxes (533 US, 10,222 OUS).

Recall Details

Product Type: Devices
Report Date: May 4, 2022
Initiation Date: Feb 22, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,755 boxes (533 US, 10,222 OUS)

Product Description

IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

Reason for Recall

Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.

Code Information

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]

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1015-2022
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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