Z-2126-2017Class II

Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative...

Name: Z-2126-2017 Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative...
Creator: BioMerieux SA
Published: 2017-01-01
License: https://open.fda.gov/license/

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

FDA source

BioMerieux SA began a recall of Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial... on 2017-01-01. FDA classified it as Class II and gives the reason as "Potential performance issue on strain categorization". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2126-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-01
Posted: 2017-05-03
Terminated: 2022-02-24
Recalling firm: bioMerieux, Inc.
Product: Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Potential performance issue on strain categorization.
FDA root cause: Other
Action: Biomerieux sent an Urgent Field Safety Notice dated January 2017, to Laboratory Manager or Laboratory Director. The Notice indicated what actions to take and included a reply form to be returned. Required actions: The following recommendations require your immediate attention to ensure the product will continue to perform per its labeled performance specifications, within its revised shelf-life of twelve (12) months. Product with NO remaining shelf life (after reduction): Identify impacted lots of ETEST Ceftriaxone TXL32 (Ref. 412302, 412303) (lots listed in Table 1 below) which are now expired after shelf-life reduction. Immediately order the replacement products appropriate for your institution. Until replacement product is available Laboratories may continue to use their now expired strips with the following recommendations: Laboratories should continue to follow their current QC procedures for ETEST Ceftriaxone TXL32 (Ref. 412302, 412303) for the lots listed in Table 1 in accordance with CLIA and local regulatory requirements, with a modification to increase the frequency of QC testing to weekly or every day of use if previous QC testing exceeds one week. Laboratories should include in the QC testing the strain N. gonorrhoeae ATCC 49226 (Expected range-MIC: 0.004-0.016 g/mL) defined as the stability indicator for ETEST Ceftriaxone TXL32 (Ref. 412302, 412303). The MIC result for this specific strain must fall in the acceptable range to confirm the validity of the QC test and performance of the ETEST with the clinical isolate. Only report results if all QC is in the acceptable ranges. When replacement product is received, discontinue using and discard impacted ETEST Ceftriaxone TXL32 (Ref. 412302, 412303) (listed in Table 1). Additional actions: Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use
Quantity in commerce: 4656 kits
Distribution: USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA
Product codes and lots: Ref 412302 1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058 1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2126-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22

Product code JWY

K945433Class IIEtest/ceftriaxone/haemophilus/pneumococcusAb Biodisk / cleared 1995-03-17

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)