Recall Z-0204-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0204-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-15

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-08-15, terminated 2022-05-05. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001. Reason: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Terminated: 2022-05-05
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, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Reason for recall

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

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