Recall Z-2027-2021— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2027-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-13

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-05-13. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001. Reason: Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-13
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 - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

Reason for recall

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

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