The Recall Desk

FDA (Devices) recall action 81475

EUROTROL INC recalled 2 products on 2018-12-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-12-05
Critical
0
Units
4,122

Why these products were recalled

Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2018-12-05

    Eurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 2 hematology quality control mixtures because microbial contamination causes incorrect measurement results.

    Product
    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-05

    Eurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 3 hematology quality control mixtures because microbial contamination causes incorrect, lower-than-assigned measurement results.

    Product
    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
    Category
    Distribution
    0 states