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CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421

CAROLINA LIQUID CHEMISTRIES CORPORATION · Model CC421 · UDI-DI 00817302021387

DNNDICDKC Prescription
7
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities

Description

ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 tests

Recalls

DateFirmReason
2010-07-26Hospira, Inc.The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.
2008-03-27EMD Chemicals IncIncorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

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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.