Recall Z-1015-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1015-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-22

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-02-22. It names one FDA 510(k) clearance: K990222. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-02-22
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K990222 — IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6Diagnostic Products Corp.·cleared 1999-02-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.