CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report

Thermo Scientific Remel Bordetella pertussis Agglutinating recalled

Remel Europe is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, distributed nationwide in the US. The recall was initiated on 23 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 2407976

Quantity recalled79 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2920-2020
FDA event ID: 86109
Recalling firm: Remel Europe, Dartford, N/A
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2020
FDA classified: 28 Aug 2020
Reported: 9 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

23 Jul 2020	Recall initiated by company
28 Aug 2020	Classified by FDA	+36 days
9 Sep 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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 and diagnostic purposes.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.

Nationwide California Missouri

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # 2407976

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Remel Europe

All 3

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Thermo Fisher Diagnostics Neisseria meningitidis Gp C/VL recalled	Remel Europe	Other	Nationwide
29 Apr 2026Device	CLASS II	Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 recalled	Remel Europe	Salmonella	Nationwide

Other Test Kits & Diagnostics recalls

All 2,663

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide