Recall Z-1886-2024— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1886-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-23

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2024-04-23. It names one FDA 510(k) clearance: K991094. Product: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.. Reason: The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-23
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K991094 — IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6Diagnostic Products Corp.·cleared 1999-05-13

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 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

Reason for recall

The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

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