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Device, General Purpose, Microbiology, Diagnostic
FDA product code LIB · Class 1 · Microbiology
217
Registered devices
10
Adverse events
13
Recalls
43
510(k) clearances
Devices with this code
Inoculating Loop 10ul flexible Typenex LP0203PF — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDOXOID SALMONELLA 100 TEST KIT — OXOID LIMITEDGlobe Scientific — GLOBE SCIENTIFIC INC.MEDLINE — MEDLINE INDUSTRIES, INC.Caplugs/Evergreen — CAPlugsREMEL — REMEL, INC.Inoculating Loop 1ul Typenex — ZHEJIANG RUNLAB TECHNOLOGY CO., LTDCaplugs/Evergreen — CAPlugsPlanet-Safe® — Diversified Biotech, Inc.REMEL — REMEL, INC.REMEL — REMEL, INC.ANAEROJAR (FULL ASSEMBLY) — OXOID LIMITEDParasite Suspensions — MICROBIOLOGICS INC.SCU Wide Cap Sampler — ITL ASIA PACIFIC SDN. BHD.Globe Scientific — GLOBE SCIENTIFIC INC.Globe Scientific — GLOBE SCIENTIFIC INC.Remel Inc- Buffered Peptone Water — REMEL, INC.Globe Scientific — GLOBE SCIENTIFIC INC.Parasite Suspensions — MICROBIOLOGICS INC.N/A — HARDY DIAGNOSTICSANAEROJAR BASE — OXOID LIMITEDStrepQuick™ — HARDY DIAGNOSTICSREMEL — REMEL, INC.Caplugs/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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