Recall Z-2066-2015 ยท LCP Assay, Glycosylated Hemoglobin
Tosoh Bioscience, Inc.
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.
| Date | Jul 14, 2015 (initiated Feb 10, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 9 boxes/5 pouches |
| Distribution | Us Nationwide Distribution in the state ID including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011434 | G7 AUTOMATED HPLC ANALYZER Tosoh Medics, Inc., Sep 18, 2001 |