CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Dimension Vista System Loci 8 Calibrator The Loci recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista System Loci 8 Calibrator The Loci 8 Calibrator is an in vitro diagnostic, distributed nationwide in the US. The recall was initiated on 9 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1184-2018
- FDA event ID
- 79412
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2017
- FDA classified
- 26 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Nov 2017 | Recall initiated by company | |
| 26 Mar 2018 | Classified by FDA | +137 days |
| 4 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
Questions about this recall
Why was it 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.
Which lots are affected?
CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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