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Pointe Scientific, Inc. Carbon Dioxide
HORIBA INSTRUMENTS INCORPORATED · Model OC702-180 · UDI-DI 00811727014979
KHS
Prescription
1
510(k) clearances
266
Adverse events
7
Recalls
35
Facilities
Description
Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only. 4 x 45ml
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.