Reported Mar 8, 2017 · Terminated
EliA Sample Diluent, Article number, 83-1023-01
Phadia US 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: Phadia US Inc · 4169 Commercial Ave · Portage, MI · 49002-9701
Is this the product you have?
- EliA Sample Diluent, Article number, 83-1023-01
- Lot codes and dates
EliA Sample DiluentArticle number83-1023-01lots JM3YJS0BJP87JK5Nand JU9C
- Amount recalled
- 5957
Where it was sold
Why it was recalled
Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
This product could cause temporary or reversible health problems — stop using it.
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