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Hardy Diagnostics

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for recall (Z-2887-2026)Hardy Diagnostics2026-08-05
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility recall (Z-2041-2025)Hardy Diagnostics2025-06-27
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium fo recall (Z-2298-2020)Hardy Diagnostics2020-06-09
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, r recall (Z-2146-2016)Hardy Diagnostics2016-07-08
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria b recall (Z-0470-2016)Hardy Diagnostics2015-12-23
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm m recall (Z-2463-2015)Hardy Diagnostics2015-08-26
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate pac recall (Z-2273-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/ recall (Z-2274-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates recall (Z-2275-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 recall (Z-2276-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places recall (Z-2277-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tub recall (Z-2278-2015)Hardy Diagnostics2015-07-29
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill recall (Z-2279-2015)Hardy Diagnostics2015-07-29
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 1 recall (Z-2192-2015)Hardy Diagnostics2015-07-22
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: recall (Z-1444-2015)Hardy Diagnostics2015-04-14

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Every clearance here is in the API, with alerts when new ones post.