Z-1226-2017Class II

ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for...

Name: Z-1226-2017 ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for...
Creator: BioMerieux SA
Published: 2017-01-18
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-01-18 / Terminated

FDA source

BioMerieux SA began a recall of ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of... on 2017-01-18. FDA classified it as Class II and gives the reason as "Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1226-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-18
Posted: 2017-02-21
Terminated: 2020-01-30
Recalling firm: bioMerieux, Inc.
Product: ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
FDA root cause: Under Investigation by firm
Action: BioMerieux sent an Urgent Field Safety Notice electronically on 1/18/2017. The notice included instructions and recommendations for users of the product. The notice included an acknowledgment form to be returned. Customers with questions were instructed to contact their BioMerieux representative. For questions regarding this recall call 919-620-3396.
Quantity in commerce: 7,160 units
Distribution: Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam
Product codes and lots: REF 412304 - 1004497830; REF 412305 - 1002884720, 1003028270, 1003075500, 1003383650, 1004018820, 1004497810, 1005161160; REF 506918 - 1002884980, 1003028290, 1003075850, 1003385930, 1003396150, 1004022170, 1004498100, 1005161470; REF 506958 - 1002885010, 1003075540, 103396550, 1004019050, 1004501930, 1005161480

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1226-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1226-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-21

Product code JWY

K990722Class IIEtest for CefuroximeAb Biodisk / cleared 1999-04-22

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)