CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

BBL Chocolate II Agar- IVD for the isolation recalled

Becton Dickinson & is recalling BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species, distributed nationwide in the US. The recall was initiated on 21 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).

Quantity recalled9,600 EA

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-0473-2023
FDA event ID: 91201
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2022
FDA classified: 9 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 Nov 2022	Recall initiated by company
9 Dec 2022	Classified by FDA	+18 days
21 Dec 2022	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

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

Nationwide

Questions about this recall

Is BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species recalled?

Yes. Becton Dickinson & recalled BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species on 21 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0473-2023.

Why was it recalled?

Which lots are affected?

UDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

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

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