Z-1015-2022Class II

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

Name: Z-1015-2022 IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-02-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-02-22 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6] on 2022-02-22. FDA classified it as Class II and gives the reason as "Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1015-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-22
Posted: 2022-04-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Product code: DHA System, Test, Human Chorionic Gonadotropin
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.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction was issued February 02, 2022 via Fed Ex. Notification provides instructions to customers to mitigate this sample carryover. Customers are requested to complete and return the Effectiveness Check questionnaire. Contact your local Siemens Healthineers technical support representative with any questions.
Quantity in commerce: 10,755 boxes (533 US, 10,222 OUS)
Distribution: 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.
Product codes and lots: 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]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1015-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1015-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-28

Product code DHA

K990222Class IIImmulite Hcg, Model Lkcg1, Lccg5, Immulite 2000 Hcg, Model L2kcg2, L2kcg6Diagnostic Products Corp. / cleared 1999-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)