Z-0684-03

Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per...

Name: Z-0684-03 Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per...
Creator: EMD Chemicals Inc
Published: 2002-12-13
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2002-12-13 / Terminated

FDA source

EMD Chemicals Inc began a recall of Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 on 2002-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0684-03
Status: Terminated
Initiated: 2002-12-13
Posted: 2003-03-26
Terminated: 2003-05-08
Recalling firm: EMD Millipore Corporation
Product: Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95
Product code: LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Reason for recall: 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.
FDA root cause: Other
Action: All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003.
Quantity in commerce: 139 cases of 10 ampules
Distribution: The Ethanol Products were distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Hawaii Chemical Co., 2363 North King Street, Honolulu, HI 96819; Krackeler Scientific Inc., 57 Broadway, Albany, NY 12202; Midland Scientific Inc., 1202 South 11th St., Omaha, NE 68108; Reagents, Inc. 4746 Sweden Rd., Charlotte, NC 28224. The Papanicolaou Stain was distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Kramer Scientific, 711 Executive Blvd, Valley Cottage, NY 10989; Laboratory Supply Company, 3069 Mercury Rd., Jacksonville, FL 32207; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Infolab, 3000 Greenhill Dr., Round Rock, TX 78664; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182.
Product codes and lots: Item #68988/95; Lot #2330; Exp. Date May 31, 2005

Product code LCH

K990516Class IIEthyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. / cleared 1999-03-31

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)