FDAFDA · Alimentos y medicamentos·N.º oficial Z-2631-2017
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Publicado el 5 de julio de 2017 · Inicio del retiro: 21 de julio de 2009
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
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Medtest Holdings, Inc.
- Distribuidor
- Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
- Lote
- Model #'s C7568-CTL and C7568-STD Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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