CLASS II Device recall · Reported 10 Jun 2015 · FDA Enforcement Report
Dimension Vista Systems LOCI Thyroid Stimulating Hormone recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista Systems LOCI Thyroid Stimulating Hormone, distributed nationwide in the US. The recall was initiated on 20 Apr 2015 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-1708-2015
- FDA event ID
- 71096
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2015
- FDA classified
- 4 Jun 2015
- Reported
- 10 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Apr 2015 | Recall initiated by company | |
| 4 Jun 2015 | Classified by FDA | +45 days |
| 10 Jun 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.
Product as listed by the FDA
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
Where it was distributed
Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
Questions about this recall
Why was it recalled?
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.
Which lots are affected?
Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.
Where was it sold?
Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
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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