Recall Z-1252-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1252-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-13

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-04-13. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001. Reason: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-13
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.·cleared 2015-11-20

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

Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

Reason for recall

Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

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