Recall Z-0007-2008 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Tosoh Bioscience Inc
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.
| Date | Oct 3, 2007 (initiated Jun 22, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 47 Boxes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.