Home › Device types › LCP
Assay, Glycosylated Hemoglobin
FDA product code LCP · Class 2 · Hematology
277
Registered devices
2,943
Adverse events
103
Recalls
249
510(k) clearances
Devices with this code
Trinity Biotech — PRIMUS CORPORATIONTinaquant Hemoglobin A1c III — Roche Diagnostics GmbHPrecimat Fructosamine — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 — CAROLINA LIQUID CHEMISTRIES CORPORATIONHemoglobin Capillary Collection System (HCCS) — BIO-RAD LABORATORIES, INC.G8 Variant Elution Buffer HSi No.1 (S) — TOSOH CORPORATIONTSKgel G8 Variant HSi — TOSOH CORPORATIONDirect Glycohemoglobin (HbA1c) Calibrator Set — STANBIO LABORATORY, L.P.ClearChem Diagnostics Inc. Hemoglobin A-1c — CLEARCHEM DIAGNOSTICS INC.290 Sample Loader — TOSOH CORPORATIONAtellica CH Fruc — Siemens Healthcare Diagnostics Inc.Pointe HbA1c for the BS480 — HORIBA INSTRUMENTS INCORPORATEDD-100 — BIO-RAD LABORATORIES, INC.Fructosamine — HORIBA INSTRUMENTS INCORPORATEDARCHITECT — Abbott GmbHCURO A1c — KPI HEALTHCARE, INC.Lucica® Glycated Albumin-L ALB R-1 — ASAHI KASEI PHARMA CORPORATIONCAPI 3 Hb A1c — SEBIATrinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment — Siemens Healthcare Diagnostics Inc.VARIANT II TURBO Link — BIO-RAD LABORATORIES, INC.VARIANT II TURBO — BIO-RAD LABORATORIES, INC.Trinity Biotech — PRIMUS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-09-18 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of |
| 2024-06-17 | Abbott Diagnostics Technologies AS | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived |
| 2024-02-07 | Siemens Healthcare Diagnostics, Inc. | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2020-06-30 | Siemens Healthcare Diagnostics, Inc. | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these cont |
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