Z-3030-2011

Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo...

Name: Z-3030-2011 Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo...
Creator: Tosoh Bioscience Inc
Published: 2011-05-25
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2011-05-25 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemoglobin F & A2 Calibrator is used as... on 2011-05-25. The reason FDA records is "The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%". 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-3030-2011
Status: Terminated
Initiated: 2011-05-25
Posted: 2011-08-17
Terminated: 2012-02-24
Recalling firm: Tosoh Bioscience Inc
Product: Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.
Product code: JPD Hemoglobin A2 Quantitation
Reason for recall: The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: TOSOH Bioscience sent an "Urgent Recall Notification" letter dated July, 25, 2011 to all affected customers. The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement. For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.
Quantity in commerce: 6 boxes/4/2 mL btls
Distribution: Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
Product codes and lots: Part Number 020019. Lot # BCAL05R. Used By Date 2011-10.

Product code JPD

K020489Class IIG7 Automated Hplc Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. / cleared 2002-05-14

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)