Home › Device types › LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
FDA product code LXG · Class 1 · Clinical Chemistry
935
Registered devices
1,545
Adverse events
28
Recalls
3
510(k) clearances
Devices with this code
Globe Scientific — GLOBE SCIENTIFIC INC.CellSHILED — EQUASHIELD MEDICAL LTD1000 red labels “To disinfect” — PLASMABIOTICSGlobe Scientific — GLOBE SCIENTIFIC INC.N/A — Scientific Device Laboratory, Inc.Gongdong — ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.SPIFE 4000 IFE Antisera Pipette Tips — HELENA LABORATORIES CORPORATIONSlide Label Printing Ribbon — BIO SB, INC.Fenwal Hand Sealer — Fresenius Kabi AGStandard connection set for ultrasound bronchoscopes FUJIFILM EB-530US — PLASMABIOTICSCARDINAL HEALTH — Cardinal Health 200, LLCGraft Washing Station — Cole Instruments IncNova — NOVA BIOMEDICAL CORPORATIONSmart Line TL Tube Luminometer — Spectral Medical IncHSS 1625, Flow Health I — Sarstedt Aktiengesellschaft & Co.KGCascade M/M-4 Cuvettes — HELENA LABORATORIES CORPORATIONGlobe Scientific — GLOBE SCIENTIFIC INC.SPIFE 4000 White Sample Tray — HELENA LABORATORIES CORPORATIONAutoclavable version of PP EEB — PLASMABIOTICSDC/RC 900 Flex ID, VA BayPines — Sarstedt Aktiengesellschaft & Co.KGStorage connection set (for plasma injection) — PLASMABIOTICSGlobe Scientific — GLOBE SCIENTIFIC INC.N/A — Scientific Device Laboratory, Inc.De-/Recapper 900 Flex ID, 115V — Sarstedt Aktiengesellschaft & Co.KG
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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