Home › Device types › JIT
Calibrator, Secondary
FDA product code JIT · Class 2 · Clinical Chemistry
785
Registered devices
362
Adverse events
55
Recalls
245
510(k) clearances
Devices with this code
Dimension® T4 Calibrator — Siemens Healthcare Diagnostics Inc.Whole Blood Calibration Standard — Chromsystems Instruments + Chemicals GmbHFluid Pack — Diamond Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsCfas Myoglobin — Roche Diagnostics GmbHAlinity — Abbott GmbHARCHITECT — Abbott GmbHCal 2 Solution — Diamond Diagnostics Inc.AU — Beckman Coulter, Inc.Access hsTnI Calibrators — Beckman Coulter, Inc.K-ASSAY® Total IgE Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCTrinity Biotech — TRINITY BIOTECH PUBLIC LIMITED COMPANYDimension Vista® V-LTYE® Diluent 3 — Siemens Healthcare Diagnostics Inc.AMH CalSet — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsARCHITECT — ABBOTT IRELANDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.Serum Calibration Standard — Chromsystems Instruments + Chemicals GmbHARCHITECT — ABBOTT LABORATORIESAtellica CH UCFP Calibrator — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Calibrator Diluent — BIO-RAD LABORATORIES, INC.ST AIA-PACK Intact PTH CALIBRATOR SET — TOSOH CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-01 | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of me |
| 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 |
| 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 |
| 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 |
| 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 |
| 2024-01-31 | Randox Laboratories Ltd. | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may exper |
| 2023-11-21 | Ortho-Clinical Diagnostics, Inc. | Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to de |
| 2023-07-25 | Siemens Healthcare Diagnostics, Inc. | There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE |
| 2023-05-08 | Ortho-Clinical Diagnostics | Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within th |
| 2020-09-22 | Siemens Healthcare Diagnostics, Inc. | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potentia |
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