G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA device recall Z-1075-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience Inc
- 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.
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- JPD
- Quantity affected
- 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,
- Date initiated
- 2010-08-18
- Date posted
- 2013-04-10
- Date terminated
- 2014-05-13
- Location
- Grove City, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (K020489) | Tosoh Medics, Inc. | 2002-05-14 |
| G7 AUTOMATED HPLC ANALYZER (K011434) | Tosoh Medics, Inc. | 2001-09-18 |