Home › Device types › LCP
Assay, Glycosylated Hemoglobin
FDA product code LCP · Class 2 · Hematology
281
Registered devices
2,959
Adverse events
103
Recalls
249
510(k) clearances
Devices with this code
Dimension Vista® Flex® reagent cartridge HbA1c KIT — Siemens Healthcare Diagnostics Inc.Trinity Biotech — PRIMUS CORPORATIONFRUCTOSAMINE (FRUC) — RANDOX LABORATORIES LIMITEDPOINTE SCIENTIFIC Fructosamine Control Set — HORIBA INSTRUMENTS INCORPORATEDTrinity Biotech — PRIMUS CORPORATIONCVS Health At Home A1C Test Kit — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDDrew Scientific — DREW SCIENTIFIC, INC.Trinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONVARIANT II TURBO — BIO-RAD LABORATORIES, INC.VARIANT II / VARIANT II TURBO — BIO-RAD LABORATORIES, INC.Hemoglobin A1c Calibrator Set — TOSOH CORPORATIOND-100 — BIO-RAD LABORATORIES, INC.ARCHITECT — Abbott GmbHTrinity Biotech — PRIMUS CORPORATIONAU — Beckman Coulter, Inc.Precipath Fructosamine — Roche Diagnostics GmbHFructosamine — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300 — CAROLINA LIQUID CHEMISTRIES CORPORATIONLucica® Glycated Albumin-L ALB R-1 — ASAHI KASEI PHARMA CORPORATIONGlycohemoglobin Pre-Fil — STANBIO LABORATORY, L.P.ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents — Siemens Healthcare Diagnostics Inc.VARIANT II TURBO Link — BIO-RAD LABORATORIES, INC.Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LA — TOSOH 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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