Home › Device types › DDR
Myoglobin, Antigen, Antiserum, Control
FDA product code DDR · Class 2 · Immunology
64
Registered devices
85
Adverse events
12
Recalls
46
510(k) clearances
Devices with this code
ADVIA Centaur® MYO +U — Siemens Healthcare Diagnostics Inc.Alinity — Abbott Ireland DiagnosticsNano-CheckTM 4 in 1 Test — NANO-DITECH CORPORATIONAtellica IM MYO — Siemens Healthcare Diagnostics Inc.Diazyme — DIAZYME LABORATORIES, INC.Atellica IM MYO — Siemens Healthcare Diagnostics Inc.Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ cTNI TestPak — Siemens Healthcare Diagnostics Inc.Stratus® CS Acute Care™ cTNI DilPak — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsElecsys Myoglobin STAT CalSet — Roche Diagnostics GmbHDiazyme — DIAZYME LABORATORIES, INC.ARCHITECT — Abbott Ireland DiagnosticsN Latex Myoglobin — Siemens Healthcare Diagnostics Products GmbHAntiserum to Human Myoglobin — KENT LABORATORIES INCAtellica IM Calibrator U — Siemens Healthcare Diagnostics Inc.CalSet Myoglobin — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge MYO — Siemens Healthcare Diagnostics Inc.Nano-CheckTM AMI 3 in 1 — NANO-DITECH CORPORATIONAccess Myoglobin — Beckman Coulter, Inc.Alere Triage® — Alere San Diego, Inc.Nano-CheckTM AMI 2 in 1 — NANO-DITECH CORPORATIONTriage — QUIDEL CARDIOVASCULAR INC.RAMP® Myoglobin TEST KIT; 25 TESTS — Response Biomedical Corp
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-21 | Abbott Laboratories | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may |
| 2019-07-02 | Roche Diagnostics Operations, Inc. | The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant My |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2016-08-08 | Siemens Healthcare Diagnostics, Inc | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2009-01-19 | Abbott Laboratories | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| 2007-09-27 | Beckman Coulter Inc | Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Che |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placem |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associa |
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