Home › Device types › KHP
Acid, Lactic, Enzymatic Method
FDA product code KHP · Class 1 · Clinical Chemistry
238
Registered devices
169
Adverse events
19
Recalls
27
510(k) clearances
Devices with this code
Alinity — Abbott GmbHReady Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT IRELANDS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYEPOC HOST 2, CA — Epocal IncHOST 2, EPOC, JAPANESE — Epocal IncSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.LA Cartridge — LifehealthStatSensor/StatStrip — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONGEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANYRAPIDPoint® 500 System — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSABL90 FLEX Analyzer — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONCalibration gas 1 — Radiometer Medical ApSDimension® Flex® reagent cartridge LA — Siemens Healthcare Diagnostics Inc.Electrode for ABL analyzers — Radiometer Medical ApSABL800 FLEX — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lot |
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lot |
| 2020-01-15 | Abbott Point Of Care Inc. | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and no |
| 2018-12-17 | Roche Diagnostics Corporation | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modul |
| 2016-10-11 | Abbott Laboratories | Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). |
| 2016-08-11 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplemen |
| 2016-07-05 | Siemens Healthcare Diagnostics Inc | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States |
| 2016-04-13 | Beckman Coulter Inc. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6 |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide cat |
| 2015-08-24 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
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