CLASS II Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
The Bio-Rad Monolisa Anti-HBs EIA recalled by Bio-Rad Laboratories
Bio-Rad Laboratories is recalling The Bio-Rad Monolisa Anti-HBs EIA is for In Vitro Diagnostic Use and it has the, distributed nationwide in the US. The recall was initiated on 27 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2398-2012
- FDA event ID
- 62850
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2012
- FDA classified
- 17 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jul 2012 | Recall initiated by company | |
| 17 Sep 2012 | Classified by FDA | +52 days |
| 26 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
Questions about this recall
Why was it recalled?
Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Which lots are affected?
All lots distributed from May 5, 2007
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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