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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic results due to contamination, which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Eurotrol Inc. is recalling HemoTrol Level 3, an in vitro diagnostic hematology quality control mixture (Catalogue number 171.003.002). The product is intended for professional use in the verification of the linearity of HemoCue Hb 201 systems. The recall involves 2,122 units with Batch Number 82467.
The recall was initiated because microbial contamination of the product causes incorrect measurement results, specifically yielding values lower than the assigned values. This defect compromises the accuracy of the quality control process for the associated hemoglobin testing systems.
The affected product was distributed worldwide, including the United States (nationwide) and countries such as 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 the UK. Users should stop using the affected product and contact Eurotrol Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- EUROTROL INC
- Affected units
- 2,122
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Number: 82467
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by EUROTROL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · EUROTROL INC
See all →- SevereEurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05
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