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Mission Control, Level 3

Diamond Diagnostics Inc. · Model DD-92003 · UDI-DI 00811403014767

JJS Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities

Description

For monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart.

Recalls

DateFirmReason
2017-09-07Radiometer America IncRadiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a r

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Data 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.