CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

Color Gram 2 (Color Gram 2 - F) recalled by BioMerieux

BioMerieux is recalling Color Gram 2 (Color Gram 2 - F), these stains are used to stain bacterial and fungal. The recall was initiated on 23 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesColor Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508

Quantity recalled8 boxes COLOR GRAM2 with 4 - 240ML bottles in each

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-2171-2018
FDA event ID: 80111
Recalling firm: BioMerieux, Marcy L'Etoile, N/A
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2018
FDA classified: 12 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

23 Mar 2018	Recall initiated by company
12 Jun 2018	Classified by FDA	+81 days
20 Jun 2018	Published in enforcement report	+8 days

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

Reason for recall

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Where it was distributed

International distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508

Where was it sold?

International distribution.

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

8 other products · FDA event 80111

This product is part of a recall event; the main page for the event is The Vitek¿ Positive Susceptibility Card is intended recalled.

Reported	Class	Recall	Company	Reason	Where
20 Jun 2018	CLASS II	The Vitek¿ Positive Susceptibility Card is intended recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek¿ 2 Anaerobic and Corynebacteria identification recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	Vidas Toxo IgG Avidity is an automated qualitative test recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek-Positive identification card (GP) is intended recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek 2 Neisseria-Haemophilus identification card recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Vitek Negative Susceptibility Card is intended recalled	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	Oxidase Reagent recalled by BioMerieux	BioMerieux	Temperature Abuse	N/A
20 Jun 2018	CLASS II	The Previ¿ Color Gram dyes are used recalled by BioMerieux	BioMerieux	Temperature Abuse	N/A

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