Recall Z-1159-2008

Bio-Rad Laboratories · initiated November 13, 2007

Terminated

Product

BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

Codes / lots: Eleven (11) Lots, as follows: Lot Numbers: 931396 Exp. 9/30/06; 935424 Exp. 3/31/07; 941886 Exp. 3/31/07; 935682 Exp. 4/30/07; 937351 Exp. 6/30/07; 941343 Exp. 3/31/08; 941428 Exp. 4/30/08; 945246 Exp. 9/30/08; 945875 Exp. 12/31/08; 945248 Exp. 10/31/08 and 945875 Exp. 12/31/08 ****

Reason for recall

False negative results due to reagent packs exhibiting low signal.

FDA-determined cause: Nonconforming Material/Component

Action taken

On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.

Details

Recall number
Z-1159-2008
Initiated
November 13, 2007
Posted by FDA
June 11, 2008
Terminated
May 23, 2011
Product code
LKJ – Antinuclear Antibody, Antigen, Control
Quantity
8,804 kits
Distribution
Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Recalling firm
Bio-Rad Laboratories, Redmond, WA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1156-2008 BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by…False negative results due to reagent packs exhibiting low signal. 11/13/2007Terminated
Z-1157-2008 BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 -…False negative results due to reagent packs exhibiting low signal. 11/13/2007Terminated
Z-1158-2008 BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 -…False negative results due to reagent packs exhibiting low signal. 11/13/2007Terminated