Recall Z-1184-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1184-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-11-09, terminated 2020-06-08. It names one FDA 510(k) clearance: K101460. Product: Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.. Reason: An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Terminated: 2020-06-08
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K101460 — LOCI 8 CALIBRATOR, MODEL KC 646Siemens Healthcare Diagnostics·cleared 2010-07-09

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

Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.

Reason for recall

An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.

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