Device product
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
Z-1840-2015
Product summary
- Event
- Event 71406
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20 vials
- Official record key
device-enforcement:Z-1840-2015
Official wording
Reason: The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Code information: lot no. 11130382, expiration date 2016-04-30
Distribution pattern: US Distribution to the states of : AZ, CA, ID, MO, and NH.
Derived failure modes
-
Labeling or packaging
label in error