Home › Device types › CJY
Azo Dye, Calcium
FDA product code CJY · Class 2 · Clinical Chemistry
55
Registered devices
372
Adverse events
10
Recalls
47
510(k) clearances
Devices with this code
ARCHITECT — ABBOTT LABORATORIESJAS Diagnostics — DREW SCIENTIFIC, INC.Piccolo General Chemistry 13 — ABAXIS, INC.ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHCAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251 — CAROLINA LIQUID CHEMISTRIES CORPORATIONJAS Diagnostics — DREW SCIENTIFIC, INC.Calcium (Ca) — RANDOX LABORATORIES LIMITEDAlinity — Abbott GmbHABX PENTRA CALCIUM AS CP — HORIBA ABX SASARCHITECT — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT BL-251 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAU — Beckman Coulter, Inc.AU — Beckman Coulter, Inc.Sirrus® Calcium LiquiColor® — STANBIO LABORATORY, L.P.ARCHITECT — Abbott GmbHCAROLINA LIQUID CHEMISTRIES CORP.™ CALCIUM REAGENT 88815 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPiccolo Basic Metabolic Panel Plus — ABAXIS, INC.CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT AU-251 — CAROLINA LIQUID CHEMISTRIES CORPORATIONVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCThermo Scientific Infinity™ — Fisher DiagnosticsPiccolo AmLyte 13 — ABAXIS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-09 | Ortho-Clinical Diagnostics, Inc. | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS |
| 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 |
| 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. |
| 2018-12-04 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Car |
| 2018-12-04 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Car |
| 2016-05-18 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/35 |
| 2013-09-04 | SEPPIM SAS | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. |
| 2013-08-29 | Vital Diagnostics, Inc. | High positive calcium bias on plasma sample versus results on serum |
| 2013-08-29 | Vital Diagnostics, Inc. | High positive calcium bias on plasma sample versus results on serum |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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