International safety notice
Alert 2678 (Technovigilance) Bio-Rad Laboratórios Brasil Ltda qUAntify Control Possibility of variation in values relating to blood, ketones and pH throughout the shelf life of specific batches.
Brazil / Anvisa · BRA · Sep 18, 2018
Key facts
| Title | Alert 2678 (Technovigilance) Bio-Rad Laboratórios Brasil Ltda qUAntify Control Possibility of variation in values relating to blood, ketones and pH throughout the shelf life of specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: qUAntify Control Technical Name: Parameters Combined in the Same Product - Class II ANVISA registration number: 80020690292 Risk Class: II Affected model: qUAntify Control Bilevel Minipak (975X) / qUAntify Plus Control Bilevel Minipak / Tube (995X) Affected serial numbers: qUAntify Control Bi-Level Minipak (975X): Lot 78770 | qUAntify Plus Control Bi-Level Minipak/Tube (995X): Lots 80510 and 80520 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIORAD LABORATÓRIOS BRASIL LTDA CNPJ 03188198000177 RUA ALFREDO ALBANO DA COSTA 100 SALAS 12 E 3 DISTRITO INDUSTRIAL LAGOA SANTA MG TEL 31 3689 9425 EMAIL BRZRABIORADCOM FABRICANTE DO PRODUTO BIORAD LABORATORIES INC 9500 JERONIMO ROAD IRVINE CA 92618 ESTADOS UNIDOS DA AMÉRICA |
| Models | 80510, 80020690292, 78770, 80520 |
| 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