FDA Device Recall Z-0007-2008: Tosoh Bioscience Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2008.

Recall Res Number

Z-0007-2008

Recalling Firm / Manufacturer

Tosoh Bioscience Inc

FEI Number

3005529799

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-06-22

Date Posted

2007-10-03

Date Terminated

2010-10-07

Product Code

JJX

Event Number

38494

Product Quantity

47 Boxes

Product Description 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.

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 Details 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.

Distribution Pattern Nationwide.

Code Information / Serial Numbers Catalog # 020661 Lot #G803536 Exp. Date August 2008

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Medical Device Recall: Z-0007-2008

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer