Recall Z-0515-2019 ยท GGM Control, Hemoglobin
EUROTROL INC
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.
| Date | Oct 18, 2018 |
| Status | Terminated |
| Reason | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| Root cause | Material/Component Contamination |
| Action | 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): N |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964052 | HEMOCUE HEMOTROL Direct Solutions, Nov 6, 1996 |