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ContrIL Spectrum Control, Level 2

INSTRUMENTATION LABORATORY COMPANY · Model 00009833650 · UDI-DI 08426950029151

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

Description

ContrIL Spectrum Control, Level 2

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.