Vitek 2 reagent cards: a) GN ID recall
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,
Why was Vitek 2 reagent cards: a) GN ID 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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,
- Recalling firm
- Organon Teknika Inc
- Quantity
- 129,321 cartons
- Distribution
- Worldwide distribution.
- Recall date
- March 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)