Z-0065-2008

Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174...

Name: Z-0065-2008 Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174...
Creator: Bio-Rad Laboratories
Published: 2007-09-05
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2007-09-05 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories began a recall of Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA on 2007-09-05. The reason FDA records is "Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0065-2008
Status: Terminated
Initiated: 2007-09-05
Posted: 2007-10-31
Terminated: 2007-11-15
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
Quantity in commerce: 46
Distribution: Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
Product codes and lots: Lot 131BHH, Catalog # 26174

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)