Device 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.
Z-2066-2015
Product summary
- Event
- Event 71493
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9 boxes/5 pouches
- Official record key
device-enforcement:Z-2066-2015
Official wording
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.
Code information: Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
Distribution pattern: Us Nationwide Distribution in the state ID including PR.
Derived failure modes
-
Labeling or packaging
incorrectly labeled