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CO2
RANDOX LABORATORIES LIMITED · Model CD129 · UDI-DI 05055273201031
KHS
Prescription
1
510(k) clearances
265
Adverse events
7
Recalls
35
Facilities
Description
The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-14 | Beckman Coulter Ireland, Inc. | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. |
| 2023-10-25 | Ortho-Clinical Diagnostics, INc. | Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2019-10-23 | Abbott GmBH & Co. KG | Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect re |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.