Recall Z-2404-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2404-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-07

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-05-07. It names one FDA 510(k) clearance: K151792. Product: Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960. Reason: Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-05-07
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 Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

Reason for recall

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.

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