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Device, General Purpose, Microbiology, Diagnostic
FDA product code LIB · Class 1 · Microbiology
217
Registered devices
8
Adverse events
13
Recalls
43
510(k) clearances
Devices with this code
Caplugs/Evergreen — CAPlugsMedline — MEDLINE INDUSTRIES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.REMEL — REMEL, INC.Caplugs/Evergreen — CAPlugsCaplugs/Evergreen — CAPlugsOxoid™ (12 places, 150 mm skirt) Antimicrobial Susceptibility Disc Dispenser — OXOID LIMITEDInoculating Needle Rigid Typenex — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDREMEL — REMEL, INC.REMEL — REMEL, INC.REAGENT SPOT INDOLE DMACA — OXOID LIMITEDOBIS MONO KIT — OXOID LIMITEDParasite Suspensions — MICROBIOLOGICS INC.REMEL — REMEL, INC.SCU Wide Cap Sampler — ITL ASIA PACIFIC SDN. BHD.RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TB — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDMedline — MEDLINE INDUSTRIES, INC.Inoculating Loop Typenex — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDCaplugs/Evergreen — CAPlugsREMEL — REMEL, INC.MEDLINE — MEDLINE INDUSTRIES, INC.RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TB — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDCaplugs/Evergreen — CAPlugsCaplugs/Evergreen — CAPlugs
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-23 | Becton Dickinson & Co. | The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instr |
| 2016-01-08 | BioMerieux SA | Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests |
| 2014-10-23 | Remel Inc | A reagent within the test may return false negative results. |
| 2014-10-23 | Remel Inc | A reagent within the test may return false negative results. |
| 2014-03-17 | Remel Inc | A reagent contained within the product may return false negative results. |
| 2014-03-17 | Remel Inc | A reagent contained within the product may return false negative results. |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negati |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negati |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negati |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negati |
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