Medical device recalls

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

Recall date
May 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1840-2015
FDA classification
Class III
Brand / firm
Bio-Rad Laboratories, Inc.
Sold / distributed
US Distribution to the states of : AZ, CA, ID, MO, and NH.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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