Corrective action for the Strep A Schnelltest-Streifen and the Strep A Schnelltest-Gerät from Innovacon
2007.09.10
Product group In-vitro diagnostics
Reference 02577/07
Corrective action of Innovacon for the Strep A Schnelltest-Streifen and the Strep A Schnelltest-Gerät (other brand names: ACON Strep A Rapid Test Strip, ACON Strep A Rapid Test Device, ACON Strep A Twist Rapid Test Device, On Call Strep A Rapid Test Strip, On Call Strep A Rapid Test Device, On Call Strep A Twist Rapid Test Device, Quick Check Strep A Rapid Test Strip, Quick Chek Strep A Rapid Test Device, Quick Check Strep A Twist Rapid Test Device, Innovacon Strep A Rapid Test Strip, Innovacon Strep A Rapid Test Device, Innovacon Strep A Twist Rapid Test Device, InstAlert Strep A Rapid Test Strip, InstAlert Strep A Rapid Test Device, InstAlert Strep A Twist Rapid Test Device, SureStep Strep A Rapid Test Strip, SureStep Strep A Rapid Test Device, SureStep Strep A Twist Rapid Test Device) because of irritation caused by compounds of the product and a lack of corresponding warning information. Customers were informed about the problem and how to avoid it.