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.
FDA Recall Z-0007-2008 · Posted 2007-10-03
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Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeJJX
Date Initiated2007-06-22
Date Terminated2010-10-07
Product Quantity47 Boxes
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.
Firm Action
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
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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