FDAFDA · Alimentos y medicamentos·N.º oficial Z-2124-2012

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Publicado el 8 de agosto de 2012 · Inicio del retiro: 9 de julio de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante: Iris Diagnostics
Distribuidor: Nationwide Distribution
Lote: Iris Diagnostics part number 800-0074, lot number 131-12.
Clasificación de riesgo: Class III
Área (FDA): device
País: United States

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Qué peligro representa

Qué hacer

Detalles del retiro

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.