Firm Initiated Recall of Reagent Red Blood Cells

DATE RECALL INITIATED :

March 28, 2001

PRODUCTS / LOT NUMBERS / EXPIRATION DATES :

Capture-R Ready-Screen (Pooled Cells):
CW021 3/16/2001
N42 3/16/2001
(Packaged as part of Test Kits Lots 05559, 05561, 07613, or 07614)

Capture-R Ready-Screen (I and II)
X2701 3/16/2001
X2801 3/16/2001
X29 3/30/2001
(Packaged as part of Test Kits Lots 05567, 05568, 07607, 07608, 09661, or 09662)

Capture-R Ready-Screen (4)
G0101 3/16/2001
G02 3/30/2001
G03 4/13/2001
(Packaged as stand-alone plates or as part of Test Kits 09672, 09673, 09674, 09675, 11732, 11733, 11734, or 11735)

Capture-R Ready-ID
ID48 3/16/2001
ID49 3/30/2001
(Packaged as part of Test Kits 05558, 07616, 07622 or 09671)

RECALLING FIRM:

Immucor
Norcross, GA

REASON:

The recalled products are used by blood bank laboratories to screen for and identify unexpected antibodies. The recalling firm received complaints involving situations in which testing with these lots failed to detect some examples of anti-Fy^a. The firm intends to ship replacement product the week of April 2, 2001. Until the replacement product has been received, the recalling firm has asked customers to conduct a second test on all patient antibody screens that are performed using the recalled lots. Upon receipt of the new product, customers were instructed to destroy the recalled lots.

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.