Recall Z-1075-2013
Tosoh Bioscience Inc · initiated August 18, 2010
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Codes / lots: 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
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-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-1075-2013
- Initiated
- August 18, 2010
- Posted by FDA
- April 10, 2013
- Terminated
- May 13, 2014
- Product code
- JPD – Hemoglobin A2 Quantitation
- 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 countries of Canada, Columbia, Chile, Brazil, and Jamaica.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH