Reported Dec 5, 2018 · Terminated
HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin…
Eurotrol 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: EUROTROL INC · 850 N Black Branch Rd · Elizabethtown, KY · 42701
Is this the product you have?
- HemoTrol Level 2- In Vitro Diagnostic Hematology quality
- control mixture Catalogue number171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems
- Lot codes and dates
- Lot Number81166
- Amount recalled
- 2000
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
This product could cause temporary or reversible health problems — stop using it.
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