The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro recall
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…
Why was The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots distributed from May 5, 2007
- Product
- 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…
- Recalling firm
- Bio-Rad Laboratories
- Quantity
- 7,400 (approximately)- All lots since distribution date May 9, 2007
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)