Recall Z-1075-2013 ยท JPD Hemoglobin A2 Quantitation
Tosoh Bioscience Inc
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
| Date | Apr 10, 2013 (initiated Aug 18, 2010) |
| Status | Terminated |
| Reason | 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. |
| 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 | 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 c |
| FDA record | Open on fda.gov |