Z-1158-2008

BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by...

Name: Z-1158-2008 BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by...
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 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a... 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-1158-2008
Status: Terminated
Initiated: 2007-11-13
Posted: 2008-06-11
Terminated: 2011-05-23
Recalling firm: Bio-Rad Laboratories Inc.
Product: BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.
Product code: LSE Epstein-Barr Virus, Other
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: 996 kits
Distribution: Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Product codes and lots: Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08

Product code LSE

K062213Class IBioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. / cleared 2006-12-08

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)