Bio-Rad Laboratories 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio-Rad Laboratories
Lot Codes / Batch Numbers
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 ****
Products Sold
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 ****
Bio-Rad Laboratories is recalling BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 te due to False negative results due to reagent packs exhibiting low signal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False negative results due to reagent packs exhibiting low signal.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026