Reported Dec 25, 2019 · Terminated
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Polymer Technology Systems
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: Polymer Technology Systems · 4600 Anson Blvd · Whitestown, IN · 46075
Is this the product you have?
ReliOn FastA1C TestSoftware Version Revision DREF Number 3055
- Lot codes and dates
- Lot Numbers1606319 1606405 1606460 1610622 1610910 1611163
- Amount recalled
- 20,825
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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