Recall Z-2066-2015
Tosoh Bioscience, Inc. · initiated February 10, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
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: Error in labeling
Action taken
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.
Details
- Recall number
- Z-2066-2015
- Initiated
- February 10, 2015
- Posted by FDA
- July 14, 2015
- Terminated
- October 1, 2015
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 9 boxes/5 pouches
- Distribution
- Us Nationwide Distribution in the state ID including PR.
- Recalling firm
- Tosoh Bioscience, Inc., South San Francisco, CA