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Blood group reagent anti-lea (murine monoclonal)bioclone
Official notice
11 Jul 2022
Last checked
11 Jul 2022
An official Health Canada notice concerns Blood group reagent anti-lea (murine monoclonal)bioclone. During an internal investigation, Ortho identified that the Anti-Lea (Anti-Le1) lot LAB170A was demonstrating weak to no reactivity with Lea positive cells. The results of the investigation demonstrated that lot LAB170A was more than two dilutions lower than the control lot, thereby these lots were failing internal testing. This issue of weak/no reactivity of Anti-Lea (Anti-Le1) antisera may be detectable in both quality control (QC) and patient samples based on weakened strength of reactivity. Recall start date: June 29, 2022 Published 2022-07-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64355
Official notice
2022-07-11
The hazard
The hazard
During an internal investigation, Ortho identified that the Anti-Lea (Anti-Le1) lot LAB170A was demonstrating weak to no reactivity with Lea positive cells. The results of the investigation demonstrated that lot LAB170A was more than two dilutions lower than the control lot, thereby these lots were failing internal testing. This issue of weak/no reactivity of Anti-Lea (Anti-Le1) antisera may be detectable in both quality control (QC) and patient samples based on weakened strength of reactivity. Recall start date: June 29, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
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Brand: Ortho-clinical Diagnostics, Blood Reagent Anti-leabioclone.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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