Recall Z-0007-2008
Tosoh Bioscience Inc · initiated June 22, 2007
Product
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Codes / lots: Catalog # 020661 Lot #G803536 Exp. Date August 2008
Reason for recall
Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.
FDA-determined cause: Nonconforming Material/Component
Action taken
Letter, dated July 2, 2006. Immediately examine inventory and quarantine product. If product was further distributed, the direct accounts are to notify their customers including a copy of the original recall letter and Notification of Recall response card.
Details
- Recall number
- Z-0007-2008
- Initiated
- June 22, 2007
- Posted by FDA
- October 3, 2007
- Terminated
- October 7, 2010
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 47 Boxes
- Distribution
- Nationwide.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH