Z-0515-2019 Class II Terminated
FDA device recall Z-0515-2019 was initiated by EUROTROL INC on October 18, 2018 and is designated Class II. Reason for recall: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values The recall status is terminated (terminated January 7, 2020). Affected quantity: 2122.
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2018
- Initiation Date
- October 18, 2018
- Termination Date
- January 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2122
Product Description
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.
Reason for Recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Distribution Pattern
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.
Code Information
Batch Number: 82467