Z-1159-2008

BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests...

Name: Z-1159-2008 BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests...
Creator: Bio-Rad Laboratories
Published: 2007-11-13
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2007-11-13 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of 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... on 2007-11-13. The reason FDA records is "False negative results due to reagent packs exhibiting low signal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1159-2008
Status: Terminated
Initiated: 2007-11-13
Posted: 2008-06-11
Terminated: 2011-05-23
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: False negative results due to reagent packs exhibiting low signal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 8,804 kits
Distribution: Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Product codes and 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 ****

Product code LKJ

K043341Class IIBioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. / cleared 2005-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)