BioMerieux SA: 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

Recall number

Z-2126-2017

Recalling firm

BioMerieux SA

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

Status

Terminated

Initiated

2017-01-01

Posted

2017-05-03

Terminated

2022-02-24

Reason

Potential performance issue on strain categorization.

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

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

Lot, serial or model codes

Ref 412302 1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058 1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030

510(k) numbers

["K945433"]

PMA numbers

not on file

Product code

JWY

Firm FEI

1000611339

Firm city

Marcy L'Etoile

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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