Home › Device types › JIS
Calibrator, Primary
FDA product code JIS · Class 2 · Clinical Chemistry
206
Registered devices
39
Adverse events
21
Recalls
130
510(k) clearances
Devices with this code
VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Anti-Tg CalSet — Roche Diagnostics GmbHVITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E — Siemens Healthcare Diagnostics Inc.HDL-C/LDL-C Calibrator — FUJIFILM WAKO PURE CHEMICAL CORPORATIONMatrix Plus Cholestereol Reference Kit — VERICHEM LABORATORIES, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSL-Type HDL-C (Reagent 1) — FUJIFILM WAKO PURE CHEMICAL CORPORATIONAIA-PACK TSH 3rd-Gen CALIBRATOR SET — TOSOH CORPORATIONCEDIA Cyclosporine PLUS High Range Calibrators (450/2000) — Microgenics CorporationHemosIL Heparin Calibrators — INSTRUMENTATION LABORATORY COMPANYARCHITECT — ABBOTT LABORATORIESGONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL — G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAIA-PACK AFP Calibrator Set — TOSOH CORPORATIONVITROS — ORTHO CLINICAL DIAGNOSTICSCRP Ultra WR Calibrator — SEKISUI DIAGNOSTICS, LLCVITROS — ORTHO CLINICAL DIAGNOSTICSLDL Cholesterol ExR Verifier Kit — VERICHEM LABORATORIES, INC.Lipoprotein (a) Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDINNOVANCE Heparin Calibrator — Siemens Healthcare Diagnostics Products GmbHAccess TSH (3rd IS) Calibrators — Beckman Coulter, Inc.Elecsys DHEAS CalSet — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-15 | Siemens Healthcare Diagnostics, Inc. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to |
| 2025-04-15 | Siemens Healthcare Diagnostics, Inc. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to |
| 2024-04-09 | QUIDELORTHO | Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause errone |
| 2022-03-08 | Abbott Laboratories | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the sp |
| 2021-07-29 | Sentinel CH SpA | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loa |
| 2020-12-22 | Fujifilm Medical Systems U.S.A., Inc. | FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may resul |
| 2018-11-29 | Ortho Clinical Diagnostics Inc | A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. |
| 2017-02-23 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspart |
| 2016-10-24 | Beckman Coulter Inc. | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. |
| 2013-06-28 | Siemens Healthcare Diagnostics, Inc | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. |
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