IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Systems HCG test kits in two configurations: 200 tests (material number 10381206, catalog number L2KCG) and 600 tests (material number 10381194, catalog number L2KCG6). The recall affects 10,755 boxes worldwide, including 533 boxes distributed in the United States across 22 states and 10,222 boxes distributed to 81 countries outside the U.S. The recalled products come from 8 production lots numbered 463, 464, 466, 467, 469, 470, 471, and 472, with specific expiration dates and UDI codes listed for each lot.
The reason for this recall is a potential for falsely elevated human chorionic gonadotropin (hCG) results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. The source document does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
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: 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. Quantity: 10,755 boxes (533 US, 10,222 OUS) Lot/code info: 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]
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.