Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1184-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 9, 2017

Date Posted: April 4, 2018

Recall Number: Z-1184-2018

Event ID: 79412

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.

Status: Terminated

Product Quantity: 989 (681 USA/308 OUS)

Code Information:

CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated