Ethyl Alcohol Clinical Standard Solutions

• • Terminated Z-1607-2008 FDA Unclassified (pre-2012) ·initiated 27 Mar 2008

  Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

• • Terminated Z-0684-03 FDA Unclassified (pre-2012) ·initiated 13 Dec 2002 ·via K990516, on the same 510(k)

  The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.

• • Terminated Z-0683-03 FDA Unclassified (pre-2012) ·initiated 13 Dec 2002 ·via K990516, on the same 510(k)

  The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K990516 ↗

FDA Product Code

DNN

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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