Remel, Inc.
Remel, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2017, with 86 FDA device recalls on record.
Top product codes for Remel, Inc.
FDA recalls by Remel, Inc.
10 most recent of 86- Z-2623-2026 — GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
- Z-1806-2026 — Yeastone Broth, 11ML, 10/BOX YY3462
- Z-1474-2026 — Campy CVA Medium 100/PK, R01272
- Z-0585-2026 — 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
- Z-2224-2025 — Strep Selective II Agar, Product Number R01859
- Z-2225-2025 — Blood/EMB, Levine 100/PK, Product Number R02041
- Z-2226-2025 — Blood/MacConkey Biplate 100/PK, Product Number R02049
- Z-2223-2025 — Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
- Z-1947-2025 — Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
- Z-1200-2025 — remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Remel, Inc.
- K162620 — Remel Spectra ESBL
- K131804 — REMEL XPECT FLU A&B
- K092407 — REMEL SPECTRA MRSA
- K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
- K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
- K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
- K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
- K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
- K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
- K031565 — XPECT INFLUENZA A/B
- K981391 — PAR-ONE
- K970832 — PYR SWAB
- K970834 — GRAM SWAB
- K970830 — REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
- K970831 — REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
- K970833 — INDOLE SWAB
- K935975 — REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
Data sourced from openFDA. This site is unofficial and independent of the FDA.