International safety notice
Alert 2677 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Creatine Kinase - Specific batch stability problems may generate errors and/or quality control results outside the low range.
Brazil / Anvisa · BRA · Sep 18, 2018
Key facts
| Title | Alert 2677 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Creatine Kinase - Specific batch stability problems may generate errors and/or quality control results outside the low range. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Creatine Kinase Technical Name: Creatine Phosphotransferase (CPK) ANVISA registration number: 80146501537 Risk Class: II Affected Model: 1,250 Tests Affected serial numbers: 87697UN18 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7356 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT LABORATORIES 100 ABBOTT PARK ROAD ABBOTT PARK ILLINOIS 60064 USA ESTADOS UNIDOS |
| Models | 1.250, 80146501537, 87697UN18 |
| Date | Sep 18, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1