CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Etest¿ Ceftriaxone TX 002-32(low) recalled by BioMerieux

BioMerieux is recalling Etest¿ Ceftriaxone TX 002-32(low), distributed nationwide in the US. The recall was initiated on 15 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference no. 412302, Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and Reference no. 412303, Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100.

Quantity recalledunknown

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-1523-2017
FDA event ID: 76201
Recalling firm: BioMerieux, Marcy L'Etoile
Classification: Class II
Status: Terminated
Recall initiated: 15 Dec 2016
FDA classified: 21 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

15 Dec 2016	Recall initiated by company
21 Mar 2017	Classified by FDA	+96 days
29 Mar 2017	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

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Where it was distributed

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

Nationwide Georgia

Questions about this recall

Is Etest¿ Ceftriaxone TX 002-32(low) recalled?

Yes. BioMerieux recalled Etest¿ Ceftriaxone TX 002-32(low) on 15 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1523-2017.

Why was it recalled?

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Which lots are affected?

Reference no. 412302, Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and Reference no. 412303, Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100.

Where was it sold?

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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