Z-1184-2018Class II

Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the...

Name: Z-1184-2018 Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-11-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-11-09 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH)... on 2017-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1184-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Posted: 2018-03-26
Terminated: 2020-06-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. " 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: [email protected].
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.
Product codes and lots: CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code JIX

K101460Class IILoci 8 Calibrator, Model Kc 646Siemens Healthcare Diagnostics / cleared 2010-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)