Voluntary Recall of Limulus Amebocyte Lysate (LAL) Reconstitution Buffer

DATE RECALL INITIATED:

April 3, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

LAL Reconstitution Buffer (Pyrosol)

226-202 1/11/2003

MANUFACTURER:

Associates of Cape Cod
704 Main Street
Falmouth, MA 02540

REASON:

The vials of Pyrosol Buffer, sold for use in reconstituting Pyrotell and Pyrotell-T products, may contain less than the 5.5 ml of buffer declared on the product label. As a result of underfilling the vials, the user will be unable to reconstitute the lyophilized 50 test Pyrotell and Pyrotell-T products, as required by the product inserts.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.