Class 2 Device Recall ETEST Ceftriaxone

• Date Initiated by Firm: January 01, 2017
• Date Posted: May 03, 2017
• Recall Status: Terminated on February 24, 2022
• Recall Number: Z-2126-2017
• Recall Event ID: 77150
• 510(K)Number: K945433
• Product Classification: Manual antimicrobial susceptibility test systems - Product Code JWY
• 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
• Code Information: Ref 412302  1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058  1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030
• Recalling Firm/ Manufacturer: BioMerieux SA; Chemin De L'Orme; Marcy L'Etoile France
• For Additional Information Contact: Tiffany Mentzel; 919-620-3393
• Manufacturer Reason for Recall: Potential performance issue on strain categorization.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWY and Original Applicant = AB BIODISK