Z-0007-2008

4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification...

Name: Z-0007-2008 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification...
Creator: Tosoh Bioscience Inc
Published: 2007-06-22
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2007-06-22 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set... on 2007-06-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0007-2008
Status: Terminated
Initiated: 2007-06-22
Posted: 2007-10-03
Terminated: 2010-10-07
Recalling firm: Tosoh Bioscience Inc
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 47 Boxes
Distribution: Nationwide.
Product codes and lots: Catalog # 020661 Lot #G803536 Exp. Date August 2008

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)