Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0685-03

Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and...

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

EMD Chemicals Inc began a recall of Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86 on . The reason FDA records is "Difficulty in reading slides due to the stain is much greener than normal". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0685-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
EMD Millipore Corporation
Product
Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.
Product code
HZJ Stain, Papanicolau
Reason for recall
Difficulty in reading slides due to the stain is much greener than normal.
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
232 bottles
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 Nos. 7062X/75, 7062X/85, and 7062X/86. Lot #2255 Exp. Date September 30, 2004