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.
- Recall Initiated
- November 9, 2017
- Posted
- March 26, 2018
- Terminated
- June 8, 2020
- Recall Number
- Z-1184-2018
- Quantity
- 989 (681 USA/308 OUS)
- Firm Location
- Newark, DE
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.
Lot / Code Info
CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Root Cause
Under Investigation by firm
Action Taken
The firm, Siemens, issued an "Urgent Medical Device Correction (VC18-01.A.US)" letter dated 11/3/2017, to US customers on November 3, 2017 and an "Urgent Field Safety Notice (VC18-01.A.OUS)" to customers outside the US in November 2017. Customers were instructed to: " Discontinue use of and discard impacted LOCI 8 CAL lot 7CD076 " Calibrate the E2 assay using an alternate lot of LOCI 8 CAL. " Review the letter with their Medical Director. " Review their inventory of this product to determine theirs laboratory's replacement needs and to provide information to Siemens for reporting to the regulatory authorities. " Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days via Fax to Customer Care Center at (312) 275-7795 or send scanned copy via email to uscctsfcaefax.healthcare@siemens.com. " Retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center, your local Siemens Technical Support Representative or call recall contact at 800-441-9250; email: heydi.calderon@siemens-healthineers.com.