Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vitek 2 reagent cards: a) GN ID Recalled by Organon Teknika Inc Due to This notice has been initiated due to potential...

Date: January 11, 2019
Company: Organon Teknika Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Organon Teknika Inc directly.

Affected Products

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,

Quantity: 129,321 cartons

Why Was This Recalled?

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

Where Was This Sold?

Worldwide distribution.

About Organon Teknika Inc

Organon Teknika Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report