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.
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Dimension Vista System LOCI 8 Calibrator lot 7CD076 (catalog number KC646) due to an increase in failed calibration events or negative bias in quality control and patient samples when using this lot to calibrate the Estradiol (E2) Assay. A total of 989 units were distributed worldwide, including 681 units in the United States and 308 units in other countries including Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain, and Switzerland.
The source document does not specify a remedy or describe what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland. Quantity: 989 (681 USA/308 OUS) Lot/code info: CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.