International safety notice
Alert 2897 (Technovigilance) - Randox Brasil LTDA - Biochemistry Control Range values for ALT (tris buffer without P5P 37C), bicarbonate and Gamma GT incorrectly assigned to specific batches.
Brazil / Anvisa · BRA · Jun 5, 2019
Key facts
| Title | Alert 2897 (Technovigilance) - Randox Brasil LTDA - Biochemistry Control Range values for ALT (tris buffer without P5P 37C), bicarbonate and Gamma GT incorrectly assigned to specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Biochemistry Control Technical Name: Parameters Combined In The Same Product - Class II ANVISA registration number: 80158990117 Risk Class: II Affected model: Level 2 Assayed Biochemistry Control - HN1530 (20x5ml) Affected serial numbers: 1308UN |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO RANDOX BRASIL LTDA CNPJ 05257628000190 RUA FERNANDES MOREIRA 415 CEP04716000 SÃO PAULO SP TEL 11 51812024 EMAIL TATIANEFERREIRARANDOXCOM FABRICANTE DO PRODUTO RANDOX LABORATORIES LTD CRUMLIN CO ANTRIM IRLANDA DO NORTE |
| Models | HN1530, 1308UN, 80158990117 |
| Date | Jun 5, 2019 |
| 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