International safety notice
Rectification of Alert 2675 (Technosurveillance) - Roche Diagnóstica Brasil Ltda.
Brazil / Anvisa · BRA · Sep 18, 2018
Key facts
| Title | Rectification of Alert 2675 (Technosurveillance) - Roche Diagnóstica Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product or case identification: Nome Comercial: CoaguChek XS PT Test Strips e CoaguChek PT Test Technical Name: SELF-TEST FOR COAGULATION PARAMETERS ANVISA registration number: 10287410553 Risk Class: III Affected model: 6 tests, 24 tests or 2 x 24 tests Affected serial numbers: Affected Products: CoaguChek ) to the code chip (S_061). Affected products distributed by Roche Diagnóstica Brasil: > CoaguChek XS PT Test (Code 04625315070) - 2x24 tests. > CoaguChek XS PT Test (Code 04625358070) - 24 tests. Affected batches: 28632012 and 29779211 > CoaguChek XS PT Test (Code 04625374190) - 6 tests. Affected products in stock at Roche Diagnóstica Brasil: > CoaguChek XS PT Test (Code 04625315070) - 2x24 tests. > CoaguChek XS PT Test (Code 04625358070) - 24 tests. > CoaguChek XS PT Test (Code 04625374190) - 6 tests. > CoaguChek PT Test (Code 06688721070) - 2x24 tests. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198511 EMAIL BRASILTECNOVIGILANCIAROCHECOM FABRICANTE DO PRODUTO ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 334498xx, 272167xx, 06688721070, S_343, 04625315070, 10287410553, 272170xx, 353606xx, 29779211, 32204011, S_303, 28632012 and 10 more |
| 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