Date Initiated by Firm | February 10, 2015 |
Date Posted | July 14, 2015 |
Recall Status1 |
Terminated 3 on October 01, 2015 |
Recall Number | Z-2066-2015 |
Recall Event ID |
71493 |
510(K)Number | K011434 |
Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
|
Product | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Product Usage:
G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. |
Code Information |
Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015 |
Recalling Firm/ Manufacturer |
Tosoh Bioscience, Inc. 6000 Shoreline Ct Ste 101 South San Francisco CA 94080-7606
|
For Additional Information Contact | Mrs. Susan H Koss 650-615-4970 Ext. 5497 |
Manufacturer Reason for Recall | The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014. |
FDA Determined Cause 2 | Error in labeling |
Action | Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764. |
Quantity in Commerce | 9 boxes/5 pouches |
Distribution | Us Nationwide Distribution in the state ID including PR. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LCP
|