CLASS II Device recall · Reported 5 Dec 2018 · FDA Enforcement Report
HemoTrol Level Vitro Diagnostic Hematology quality control mixture recalled
Eurotrol is recalling HemoTrol Level Vitro Diagnostic Hematology quality control mixture, distributed nationwide in the US. The recall was initiated on 18 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0514-2019
- FDA event ID
- 81475
- Recalling firm
- Eurotrol, Elizabethtown, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2018
- FDA classified
- 28 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Oct 2018 | Recall initiated by company | |
| 28 Nov 2018 | Classified by FDA | +41 days |
| 5 Dec 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Austria, Australia, Bahrain, France, Hong Kong, Indonesia, Ireland, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Maldives, New Zealand, Mozambique, Pakistan, Poland, Slovenia, Africa, Spain, Thailand, Finland, Norway, and UK.
Questions about this recall
Why was it recalled?
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Which lots are affected?
Lot Number: 81166
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Austria, Australia, Bahrain, France, Hong Kong, Indonesia, Ireland, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Maldives, New Zealand, Mozambique, Pakistan, Poland, Slovenia, Africa, Spain, Thailand, Finland, Norway, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81475This product is part of a recall event; the main page for the event is HemoTrol Level Vitro Diagnostic Hematology quality control mixture recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HemoTrol Level Vitro Diagnostic Hematology quality control mixture recalled | Eurotrol | Sterility | Nationwide |
More recalls from Eurotrol
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HemoTrol Level Vitro Diagnostic Hematology quality control mixture recalled | Eurotrol | Sterility | Nationwide |
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