Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1840-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-05-13 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1840-2015
Date of alert: 2015-05-13
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Bio-Rad Laboratories, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11130382

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1840-2015 — 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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