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Pointe Ethyl Alcohol Calibrator (100 mg/dL)
HORIBA INSTRUMENTS INCORPORATED · Model 60-EA0446-5 · UDI-DI 00811727017413
DNN
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities
Description
Pointe Ethyl Alcohol Calibrator (100 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Calibrators are for use as calibrators in the quantitation of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on a number of automated clinical chemistry analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-07-26 | Hospira, 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. |
| 2008-03-27 | EMD Chemicals Inc | Incorrect 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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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.