• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Recall of Amplicor HIV-1 Monitor Test, v 1.5-Roche Molecular Systems, Inc

 

DATE RECALL INITIATED:

June 24, 2004

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate, Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018, expiration January, 2005

Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase)BGG Conjugate, Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123, expiration September, 2004

NOTE: This product was only distributed to foreign consignees.

MANUFACTURER:

Roche Molecular Systems, Inc
Belleville, New Jersey

REASON:

Roche has confirmed increased frequency of occurrence of "blue foci" with the Avidin-Horseradish Peroxidase (AV-HRP) Conjugate Lot E09659. This lot is included as a component in the kits listed above. "Blue foci" are blue particulates in the microwell plate that are visible in manual methods following the addition of conjugate and substrate to the wells during the detection process. Increased frequency of the occurrence of "blue foci" may lead to elevated and/or observed out of sequence optical density readings in the microwell plate assays that have used this particular lot of reagent. The investigation determined that AV-HRP Conjugate, Lot E09659, exhibited a higher frequency of "blue foci" when compared to previous lots of conjugate, and that the frequency of blue foci in this particular lot may be increasing with the age of the reagent. Consignees have been asked to contact the manufacturer to arrange for product return.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002