Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemog
FDA device recall Z-3030-2011 · posted 2011-08-17 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience Inc
- Reason for recall
- The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.
- Action taken
- TOSOH Bioscience sent an "Urgent Recall Notification" letter dated July, 25, 2011 to all affected customers. The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement. For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JPD
- Quantity affected
- 6 boxes/4/2 mL btls
- Distribution
- Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
- Date initiated
- 2011-05-25
- Date posted
- 2011-08-17
- Date terminated
- 2012-02-24
- 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 |