FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
- Recall number
- Z-1620-2010
- Recalling firm
- Bio-Rad Laboratories
- Product
- Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
- Status
- Terminated
- Initiated
- 2008-08-11
- Posted
- 2010-05-20
- Terminated
- 2010-05-20
- Reason
- The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.
- Root cause
- Packaging process control
- Action
- All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723.
- Quantity
- 795 kits
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Lot #'s: 288BEE and 056CEE
- 510(k) numbers
- not on file
- PMA numbers
- ["P050048"]
- Product code
- LOM
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28