Reported Jul 1, 2015 · Terminated

The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately…

Bio-Rad Laboratories, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories, Inc. · 6565 185th Ave NE · Redmond, WA · 98052-5039

Is this the product you have?

  • 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.
Lot codes and dates
    • lot no. 11130382
    • expiration date 2016-04-30
Amount recalled
20 vials

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 5, 2015 · Data as of Sep 19, 6:12 PM UTC

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