—#162252

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.

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K101460
Affected lot / code info: CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2017-11-09
Posted by FDA: 2018-03-26
Terminated: 2020-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.