Z-1184-2018 Class II Terminated
FDA device recall Z-1184-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on November 9, 2017 and is designated Class II. 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… The recall status is terminated (terminated June 8, 2020). Affected quantity: 989 (681 USA/308 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- November 9, 2017
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 989 (681 USA/308 OUS)
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
Code Information
CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401