International safety notice
Alert 2793 (Technovigilance) - Beckman Coulter Do Brasil - iChem Velocity Urine Chemistry Strips - Possibility of falsely elevated results for urobilinogen, in specific batches.
Brazil / Anvisa · BRA · Feb 4, 2019
Key facts
| Title | Alert 2793 (Technovigilance) - Beckman Coulter Do Brasil - iChem Velocity Urine Chemistry Strips - Possibility of falsely elevated results for urobilinogen, in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: iChem Velocity Urine Chemistry Strips Technical Name: Urine Test Strip ANVISA registration number: 10033120946 Risk Class: II Affected model: 01 Bottle with 100 Strips Affected serial numbers: Part Number: 800-7212 - Lots: 7212165.2 A; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA CNPJ 42160812000144 AL RIO NEGRO 500 TORRE B 15º ANDAR ALPHAVILLE INDUSTRIAL BARUERI SP TEL 11 41548813 EMAIL DMWOLINGERBECKMANCOM FABRICANTE DO PRODUTO IRIS DIAGNOSTICS A DIVISION OF IRIS INTERNATIONAL INC 9172 ETON AVE CHATSWORTH CA 91311 ESTADOS UNIDOS DA AMÉRICA EUA |
| Models | 7212171, 10033120946, 7204200, 7204193, 800-7204, 7212168, 7204202, 7204207, 7204204, 7212165.2, 800-7212 |
| Date | Feb 4, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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.
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