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U.S. Department of Health and Human Services

Class 3 Device Recall AntiHBs Cutoff Calibrator Catalog 26154

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  Class 3 Device Recall AntiHBs Cutoff Calibrator Catalog 26154 see related information
Date Initiated by Firm May 13, 2015
Date Posted June 25, 2015
Recall Status1 Terminated 3 on November 05, 2015
Recall Number Z-1840-2015
Recall Event ID 71406
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
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.

Code Information lot no. 11130382, expiration date 2016-04-30
Recalling Firm/
Bio-Rad Laboratories, Inc.
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Technical Support
Manufacturer 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.
FDA Determined
Cause 2
Incorrect or no expiration date
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.
Quantity in Commerce 20 vials
Distribution US Distribution to the states of : AZ, CA, ID, MO, and NH.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.