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U.S. Department of Health and Human Services

Class 2 Device Recall LOCI 8 Calibrator

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  Class 2 Device Recall LOCI 8 Calibrator see related information
Date Initiated by Firm November 09, 2017
Date Posted March 26, 2018
Recall Status1 Terminated 3 on June 08, 2020
Recall Number Z-1184-2018
Recall Event ID 79412
510(K)Number K101460  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
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.
Code Information CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 989 (681 USA/308 OUS)
Distribution Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS