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POINTE SCIENTIFIC Alcohol Standard
HORIBA INSTRUMENTS INCORPORATED · Model A7504-STD · UDI-DI 00811727010087
DNN
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities
Description
The Alcohol standard is intended as a means of calibrating various ethanol assay methods.
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.