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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe).
Plain-English summary
Eurotrol Inc. is recalling 2,000 units of HemoTrol Level 2 In Vitro Diagnostic Hematology quality control mixture, catalogue number 171.002.002, lot number 81166. The product is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems.
The recall was initiated because microbial contamination of the product causes incorrect measurement results, specifically values lower than the assigned values. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in 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 lot and contact Eurotrol Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- EUROTROL INC
- Affected units
- 2,000
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)
- Lot Number: 81166
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 →- HighEurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05
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