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Recall Observatory FDA recall evidence

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

May 13, 2015

Class III

Product summary

Firm
Bio-Rad Laboratories, Inc.
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

    reason.labeling_packaging · v1.0.0

    label in error