Home › Device types › JIT
Calibrator, Secondary
FDA product code JIT · Class 2 · Clinical Chemistry
786
Registered devices
365
Adverse events
55
Recalls
245
510(k) clearances
Devices with this code
Alinity — Abbott GmbHST AIA-PACK SHBG CALIBRATOR SET — TOSOH CORPORATIONDimension Vista® Flex® reagent cartridge HbA1c KIT — Siemens Healthcare Diagnostics Inc.CalSet IGF-1 — Roche Diagnostics GmbHDimension Vista® V-LTYE® Dilution Check — Siemens Healthcare Diagnostics Inc.K-ASSAY® Cystatin C Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCAlinity — ABBOTT IRELANDQUANTA Flash RF IgM Calibrators — INOVA DIAGNOSTICS, INC.ARCHITECT — ABBOTT IRELANDAtellica IM IRI Calibrator — Siemens Healthcare Diagnostics Inc.B.R.A.H.M.S PlGF plus KRYPTOR CAL — B.R.A.H.M.S GmbHFRUCTOSAMINE (FRUC) — RANDOX LABORATORIES LIMITEDAlinity c Acetaminophen Calibrator — Sekisui Diagnostics, LLCAtellica IM CYFRA21-1 Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAlinity — Abbott Ireland DiagnosticsAtellica CH UAlb CAL — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D — CAROLINA LIQUID CHEMISTRIES CORPORATIONAU — BECKMAN COULTER IRELAND INC.Access sTfR Calibrators — Beckman Coulter, Inc.ABX PENTRA HDL CAL — HORIBA ABX SASVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Elecsys LH CalSet II — Roche Diagnostics GmbHAccess 25(OH) Vitamin D Total Calibrators — Beckman Coulter, Inc.
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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