Z-1532-2017Class II

ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a...

Name: Z-1532-2017 ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a...
Creator: BioMerieux SA
Published: 2016-12-15
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-12-15 / Terminated

FDA source

BioMerieux SA began a recall of ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial... on 2016-12-15. FDA classified it as Class II and gives the reason as "Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1532-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Posted: 2017-03-21
Terminated: 2020-08-18
Recalling firm: bioMerieux, Inc.
Product: ETEST Ceftriaxone TXL32 FOAM packaging, 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
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
FDA root cause: Storage
Action: biomerieux sent an Urgent Field Safety Notice dated December 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify the affected lots and immediately order the replacement products. Laboratories should continue to follow their current QC procedures. When replacement product is received, consignees should discontinue using any discard affected product. Consignees should distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward the information to all parties that may use this product, including others to whom they may have transferred our product. Consignees should contact their bioMerieux representative for product compensation. Consignees should also complete and return the Acknowledgment Form in Attachment A by Fax to confirm receipt of the notice. Consignees with questions should contact their local bioMerieux Clinical Customer Service representative. For questions regarding this recall call 314-731-8516.
Quantity in commerce: unknown
Distribution: 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
Product codes and lots: Reference no. 507058, Lot #1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030 and Reference no. 507018, Lot #1002940880, 1003182290, 1003813700, 1003851130, 1003953490, 1004239880, 1004316460, 1004527210, 1004755930, 1004828450, 1004876850 & 1004919010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1532-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1521-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1522-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1523-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1524-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1525-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1526-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1527-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1528-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1529-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1530-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1531-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1532-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code JWY

K980345Class IIEtest CeftriaxoneAb Biodisk / cleared 1998-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)