HemoTrol Level 3- In Vitro Diagnostic Hematology recall: Contamination
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin…
Why was HemoTrol Level 3- In Vitro Diagnostic Hematology recalled?
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Number: 82467
- Product
- HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin…
- Recalling firm
- EUROTROL INC
- Quantity
- 2122
- Distribution
- 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.
- Recall date
- December 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)