FDA Medical Device Recalls (openFDA)
EMD Chemicals Inc: Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
- Recall number
- Z-0683-03
- Recalling firm
- EMD Chemicals Inc
- Product
- Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
- Status
- Terminated
- Initiated
- 2002-12-13
- Posted
- 2003-03-26
- Terminated
- 2003-05-08
- Reason
- 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.
- 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
- 279 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.
- Lot, serial or model codes
- Item # 68996/95 Lot #1295; Exp. Date April 30,2004
- 510(k) numbers
- ["K990516"]
- PMA numbers
- not on file
- Product code
- LCH
- Firm FEI
- 2244894
- Firm city
- Gibbstown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28