Class 2 Device Recall Vitek 2

• Date Initiated by Firm: January 11, 2019
• Create Date: February 27, 2019
• Recall Status: Terminated on November 06, 2020
• Recall Number: Z-0962-2019
• Recall Event ID: 81934
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: Vitek 2 reagent cards:; a) GN ID, REF 21341,; b) GP ID, REF 21342,; c) ANC ID, REF 21347, ; d) AST-GNOR, REF 22000,; e) AST-GP67, REF 22226, ; f) AST-P612, REF 22359, ; g) AST-XN01, REF 410025,; h) AST-N222, REF 413083, ; i) AST-N223, REF 413110,; j) AST-N226, REF 413143, ; k) AST-N248, REF 413397,; l) ASR-GN67, REF 413399,; m) AST-GN69, REF 413400,; n) AST-GN73, REF 413404,; o) AST-GN79, REF 413436,; p) AST-GN82, REF 413439,; q) AST-N261, REF 413753,; r) AST-XN06, REF 413944,; s) AST-N275, REF 414313,; t) AST-GP75, REF 415670,; u) AST-N300, REF 416241,; v) AST-N308, REF 413913,; w) AST-N314, REF 417027,; x) AST-N318, REF 417952,; y) AST-P643, REF 418671,; z) AST-YS08, REF 420739, ; aa) AST-N348, REF 420856,; bb) AST-ST02, REF 420915,; cc) AST-ST03, REF 421040,; dd) AST-N355, REF 421351,; ee) AST-P654, REF 421912, ; ff) AST-P655, REF 421913,; gg) AST-N371, REF 422024,; hh) AST-N372, REF 422241,; ii) AST-N379, REF 423052,
• Code Information: a) GN ID, REF 21341: Lot Numbers: 2410602403, 2410624103, 2410632203, 2410635203, 2410636203, 2410637203 b) GP ID, REF 21342, Lot Numbers: 2420806103, 2420818403, 2420822203 c) ANC ID, REF 21347, Lot Numbers: 2440811203 d) AST-GNOR, REF 22000, Lot Numbers: 1010810203 e) AST-GP67, REF 22226, Lot Numbers: 1320808103, 1320816203, 1320820403 f) AST-P612, REF 22359, Lot Numbers: 4920814403 g) AST-XN01, REF 410025, Lot Numbers: 3130813203 h) AST-N222, REF 413083, Lot Numbers: 6220813203 i) AST-N223, REF 413110, Lot Numbers: 6230811103 j) AST-N226, REF 413143, Lot Numbers: 6260813203 k) AST-N248, REF 413397, Lot Numbers: 6480817203 l) ASR-GN67, REF 413399, Lot Numbers: 5870818203 m) AST-GN69, REF 413400, Lot Numbers: 5890803203, 5890806203, 5890820203 n) AST-GN73, REF 413404, Lot Numbers: 5930821203 o) AST-GN79, REF 413436, Lot Numbers: 5990817203 p) AST-GN82, REF 413439, Lot Numbers: 6720813203 q) AST-N261, REF 413753, Lot Numbers: 6610807203 r) AST-XN06, REF 413944, Lot Numbers: 1490809103 s) AST-N275, REF 414313, Lot numbers: 6950810203 t) AST-GP75, REF 415670, Lot Numbers: 2750809103, 2750823203 u) AST-N300, REF 416241, Lot Numbers: 7200810203 v) AST-N308, REF 413913, Lot Numbers: 7280810203 w) AST-N314, REF 417027, Lot Numbers: 7540810203 x) AST-N318, REF 417952, Lot Numbers: 7580813203 y) AST-P643, REF 418671, Lot Numbers: 7430809203 z) AST-YS08, REF 420739, Lot Numbers: 2880809203, 2880812203 aa) AST-N348, REF 420856, Lot Numbers: 7880811203 bb) AST-ST02, REF 420915, Lot Numbers: 5410812203 cc) AST-ST03, REF 421040, Lot Numbers: 5420809203, 5420812203 dd) AST-N355, REF 421351, Lot Numbers: 7950805203 ee) AST-P654, REF 421912, Lot Numbers: 8040822203 ff) AST-P655, REF 421913, Lot Numbers: 8050823203 gg) AST-N371, REF 422024, Lot Numbers: 210805204 hh) AST-N372, REF 422241, Lot Numbers: 220810404 ii) AST-N379, REF 423052, Lot Numbers: 290815204
• Recalling Firm/ Manufacturer: Organon Teknika Inc; 100 Rodolphe St Bldg 1300; Durham NC 27712-9402
• Manufacturer Reason for Recall: This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards
• FDA Determined Cause: Process control
• Action: The recall was issued to bioM¿rieux subsidiaries and distributors via email notification on Friday, January 11th, 2019. Impacted customers were notified via correction notice (customer letter) issued on 01/19/2019 from each associated subsidiary/distributor onto local letterhead. The letter directed the user to perform a "tug test" to determine if the product is defective. Defective units were to be discarded and a credit issued.
• Quantity in Commerce: 129,321 cartons
• Distribution: Worldwide distribution.
• 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.