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.
FDA Recall Z-1840-2015 · Posted 2015-06-25
Recalling FirmBio-Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeJJX
Date Initiated2015-05-13
Date Terminated2015-11-05
Product Quantity20 vials
Reason for Recall
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.
Firm Action
Bio-Rad Laboratories Inc, sent an Urgent Product Correction letter dated May 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The recalled calibrator is a spare component which is sold separately from the MONOLISA Anti-HBs EIA Kit and the kit is not affected by this recall.
Customers were informed that testing was performed and the Anti-HBs 10 mLU/mL Calibrator was acceptable to use through the expiration date of the kit dated 2015-11-30.
Customers with questions can call the firm at 1-800-224-6723, option #2, then #3.
Root Cause
Incorrect or no expiration date
Distribution Pattern
US Distribution to the states of : AZ, CA, ID, MO, and NH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.