VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL— 510(k) K172944

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LON

Device class

Class 2

Regulation

21 CFR 866.1645

Advisory panel

Microbiology

Date received

2017-09-26

Decision date

2017-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance2026-04-15
• K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)2026-03-26
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)2025-08-21
• K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)2025-08-08
• K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)2025-05-19

• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2026-07-08
• K234012 — VITEK COMPACT PRO2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12
• K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)2024-06-07
• K240279 — VIDAS TBI (GFAP, UCH-L1)2024-05-01

Malfunction

2,383

Total

2,383

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1236-2026 — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309Class II·Ongoing·Biomerieux Inc·20260105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172944.