Dimension Vista System LOCI 8 CALIBRATOR recallZ-1184-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 9, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1184-2018
- Status
- Terminated
- Initiated by the company
- Nov 9, 2017
- Posted by the FDA
- Mar 26, 2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 989 (681 USA/308 OUS)
- Product code
- JIX
- FDA submissions
- K101460
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
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.
Code information (models, lots, serial numbers)
CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension Vista® LOCI 8 CAL 10488192Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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