Recall Z-0515-2019
Eurotrol Inc · initiated October 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Batch Number: 82467
Reason for recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
FDA-determined cause: Material/Component Contamination
Action taken
Eurotrol distributors and initial consignees contacted via e-mail with the recall notification letter on 10/16/18. The recall notification letter sent via overnight mail in case e-mail is not deliverable. The recall notification letter instructs distributors how to perform the subrecall towards end-users and inform Eurotrol about the performed subrecall actions Primary instruction will be to stop using the product (discard according local regulation on medical waste) and contact Eurotrol for replacement material. Questions, contact (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time): Name: Eurotrol Inc. Address 850 N Black Branch Rd. Zipcode & city: Elizabethtown, KY 42701 USA Phone: T +1 502 501 1180 E-mail: officeusa@eurotrol.com.
Details
- Recall number
- Z-0515-2019
- Initiated
- October 18, 2018
- Terminated
- January 7, 2020
- Product code
- GGM – Control, Hemoglobin
- 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.
- Recalling firm
- Eurotrol Inc, Elizabethtown, KY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0514-2019 Class II | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue…Incorrect measurement results caused by microbial contamination of the product, results in values lower than… | 10/18/2018Terminated |