CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

BEA Agar with Vancomycin container type recalled by Hardy Diagnostics

Hardy Diagnostics is recalling BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve, distributed nationwide in the US. The recall was initiated on 26 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

Quantity recalled5,940 (5940 pk/10)

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-2276-2015
FDA event ID: 71602
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2015
FDA classified: 29 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

26 Jun 2015	Recall initiated by company
29 Jul 2015	Classified by FDA	+33 days
5 Aug 2015	Published in enforcement report	+7 days

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

Reason for recall

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

Where it was distributed

U.S. Nationwide Distribution and the country of: Canada

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

Where was it sold?

U.S. Nationwide Distribution and the country of: Canada

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.

Other products in this recall event

6 other products · FDA event 71602

This product is part of a recall event; the main page for the event is VRE Broth container type: 16x100mm tube packaged: 20 tubes/box fill recalled.

Reported	Class	Recall	Company	Reason	Where
5 Aug 2015	CLASS II	VRE Broth container type: 16x100mm tube packaged: 20 tubes/box fill recalled	Hardy Diagnostics	Packaging Defects	Nationwide
5 Aug 2015	CLASS II	BEA Agar with VGA container type recalled by Hardy Diagnostics	Hardy Diagnostics	Packaging Defects	Nationwide
5 Aug 2015	CLASS II	BHI with Cipro, 1ug/ml container type recalled by Hardy Diagnostics	Hardy Diagnostics	Packaging Defects	Nationwide
5 Aug 2015	CLASS II	MacConkey Agar with CiPRP, 1ug/ml Container type recalled	Hardy Diagnostics	E. coli	Nationwide
5 Aug 2015	CLASS II	MDR Acinetobacter container type recalled by Hardy Diagnostics	Hardy Diagnostics	Packaging Defects	Nationwide
5 Aug 2015	CLASS II	BEA Broth with Vancomycin container type recalled by Hardy Diagnostics	Hardy Diagnostics	Packaging Defects	Nationwide

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All 20

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30 Dec 2020Device	CLASS II	Viral Transport Medium recalled by Hardy Diagnostics	Hardy Diagnostics	Foreign Material	Nationwide

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