Home › Device types › LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
FDA product code LXG · Class 1 · Clinical Chemistry
896
Registered devices
1,540
Adverse events
28
Recalls
3
510(k) clearances
Devices with this code
Recapper RC1200 LiaisonXL,115V — Sarstedt Aktiengesellschaft & Co.KGDe-/Recapper 900 Flex ID, 115V — Sarstedt Aktiengesellschaft & Co.KGSeraplas — Sarstedt Aktiengesellschaft & Co.KGGlobe Scientific — GLOBE SCIENTIFIC INC.LabChoice Flexible Inoculation Loops, Blue, Sterile, 10 ul — Dynarex CorporationCellSHILED — EQUASHIELD MEDICAL LTDSmartPractice — Smarthealth, Inc.LabChoice Rigid Inoculation Loops, Transparent, Sterile, 1 ul — Dynarex CorporationDe-/Recapper 900 Flex ID, 115V — Sarstedt Aktiengesellschaft & Co.KGHYDROFLEX ELISA — Tecan Austria GmbHGlobe Scientific — GLOBE SCIENTIFIC INC.Prefilter — Chromsystems Instruments + Chemicals GmbHAutoclavable version of PW Enew — PLASMABIOTICSAliquoter & Labeler, TCA — Thermo Fisher Scientific OyFisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.POREX SQ-EASY — POREX CORPORATIONKBMED — KB Medical (group), Inc.De-/Recapper 900 Flex ID,115 V — Sarstedt Aktiengesellschaft & Co.KG3D Bag Set — Thermogenesis Corp.Corning — Corning IncorporatedGlobe Scientific — GLOBE SCIENTIFIC INC.Gastrolyzer — BEDFONT SCIENTIFIC LIMITEDEndocator Starter Kit — Vista DentalYumizen T6000 — HORIBA ABX SAS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-15 | Sysmex America, Inc. | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. |
| 2025-07-16 | Dynex Technologies, Inc. | The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidenti |
| 2023-05-02 | Helena Laboratories, Corp. | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of misse |
| 2020-07-05 | Dynex Technologies, Inc. | Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control f |
| 2020-03-09 | Sysmex America, Inc. | Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover |
| 2019-09-18 | Biomedical Polymers, Inc. | The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead o |
| 2019-09-18 | Biomedical Polymers, Inc. | The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead o |
| 2018-08-14 | Siemens Healthcare Diagnostics, Inc. | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
| 2018-08-14 | Siemens Healthcare Diagnostics, Inc. | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
| 2018-08-14 | Siemens Healthcare Diagnostics, Inc. | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
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