Z-0265-2018Class II

ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the...

Name: Z-0265-2018 ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the...
Creator: BioMerieux SA
Published: 2017-04-13
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-04-13 / Terminated / root cause: packaging

FDA source

BioMerieux SA began a recall of ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species on 2017-04-13. FDA classified it as Class II and gives the reason as "QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0265-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2017-12-19
Terminated: 2020-08-18
Recalling firm: bioMerieux, Inc.
Product: ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: BioMerieux sent an Urgent Field Safety Notice on April 30, 2017. Short-term Action: Subsidiaries and distributors are required to discard all ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.
Quantity in commerce: 1585 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
Product codes and lots: REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0264-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-19
Z-0265-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-19

Product code JWY

K913459Class IIThe E Test, ModificationAb Biodisk / cleared 1991-09-25

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)