Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1015-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 22, 2022

Date Posted: May 4, 2022

Recall Number: Z-1015-2022

Event ID: 89900

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.

Status: Ongoing

Product Quantity: 10,755 boxes (533 US, 10,222 OUS)

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]

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.

Voluntary or Mandated:

Voluntary: Firm initiated