Reported Sep 12, 2012 · Terminated
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine…
Capintec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Capintec Inc · 620 Alpha Dr · Pittsburgh, PA · 15238
Is this the product you have?
- Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
- Lot codes and dates
- Catalog numbers for new systems
5430-00765430-00775430-0103and 5430-0087
- Catalog numbers for conversion systems5430-0118 and 5430-0119
- Serial numbers for new systems901006 through 901394, inclusive
- Serial numbers for conversion systemsCNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)
- Catalog numbers for new systems
- Amount recalled
- 256
Where it was sold
- Nationwide
Why it was recalled
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
This product could cause temporary or reversible health problems — stop using it.
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