4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaH
FDA device recall Z-0007-2008 · posted 2007-10-03 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience Inc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 47 Boxes
- Distribution
- Nationwide.
- Date initiated
- 2007-06-22
- Date posted
- 2007-10-03
- Date terminated
- 2010-10-07
- Location
- Grove City, OH
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