Tosoh Bioscience Inc: Medical Device Recall in 2013 - (Recall #: Z-1075-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 18, 2010

Date Posted: April 17, 2013

Recall Number: Z-1075-2013

Event ID: 56584

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.

Status: Terminated

Product Quantity: 633

Code Information:

11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated