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

Recall Z-2920-2020 — Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological an

U.S. FDA — Device Enforcement · United Kingdom · 2020-07-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2920-2020
Date of alert: 2020-07-23
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Remel Europe Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05056080501826

Reported risk: Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

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.

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