Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2012
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 a
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 coul…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bio-Rad Laboratories recalled The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog n… - a moderate-severity action.
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog n… was recalled by Bio-Rad Laboratories in September 26, 2012. Reason: Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated O…. Check the official notice for the remedy. Verify recall #Z-2398-2012 with the FDA Devices before acting.
The recall
Bio-Rad Laboratories issued this moderate-severity FDA Devices recall-Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated O….
- Moderate
- severity level
- Class II
- classification
- September 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2398-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2398-2012) was formally reported on September 26, 2012, with the manufacturer initiating the action on July 27, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Bio-Rad Laboratories is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 7,400 (approximately)- All lots since distribution date May 9, 2007.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7,400 (approximately)- All lots since distribution date May 9, 2007
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2398-2012 |
| Date reported | September 26, 2012 |
| Date initiated | July 27, 2012 |
| Recalling firm | Bio-Rad Laboratories |
| Firm location | Redmond, WA |
| Affected scope | 7,400 (approximately)- All lots since distribution date May 9, 2007 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2398-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bio-Rad Laboratories. Units affected: 7,400 (approximately)- All lots since distribution date May 9, 2007.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2398-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2398-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.