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
Atellica CH Billirubin Calibrator (BILI CAL) — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESDimension® TBI/DBI Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsVITROS — ORTHO CLINICAL DIAGNOSTICSVITROS — ORTHO CLINICAL DIAGNOSTICSDRI Thyroxine (T4) Calibrator Kit — Microgenics CorporationCRP CAL — RANDOX LABORATORIES LIMITEDAnti-Tg CalSet — Roche Diagnostics GmbHChloroChek® Standard Solution, 100 mmol/L, 10x1mL — ELITECHGROUP INC.Access Cortisol Calibrators — Beckman Coulter, Inc.Chemistry 2 Install Standard Kit — VERICHEM LABORATORIES, INC.CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STD — CAROLINA LIQUID CHEMISTRIES CORPORATIONMatrix Plus Cholesterol, Level F — VERICHEM LABORATORIES, INC.CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCRP CAL — RANDOX LABORATORIES LIMITEDDimension® CCRP Calibrator — Siemens Healthcare Diagnostics Inc.GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL — G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.VITROS — ORTHO CLINICAL DIAGNOSTICSAccess TSH (3rd IS) Calibrators — Beckman Coulter, Inc.Access Progesterone II Calibrators — Beckman Coulter, Inc.Dimension Vista® TIBC CAL — Siemens Healthcare Diagnostics Inc.HDL Ultra Calibrator Kit — Sekisui Diagnostics, LLC
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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