Z-1075-2013Class III

G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood

Name: Z-1075-2013 G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood
Creator: Tosoh Bioscience Inc
Published: 2010-08-18
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2010-08-18 / Terminated

FDA source

Tosoh Bioscience Inc began a recall of G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood on 2010-08-18. FDA classified it as Class III and gives the reason as "The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1075-2013
Classification: Class III
Status: Terminated
Initiated: 2010-08-18
Posted: 2013-04-10
Terminated: 2014-05-13
Recalling firm: Tosoh Bioscience Inc
Product: G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Product code: JPD Hemoglobin A2 Quantitation
Reason for recall: The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.
FDA root cause: Component change control
Action: Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.
Quantity in commerce: 633
Distribution: Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
Product codes and lots: 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-09

Product code JPD

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)