AQUIOS Lyse Reagent Kit recall
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit…
Why was AQUIOS Lyse Reagent Kit recalled?
Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.
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?
6040014K 6040015K
- Product
- AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 2367 units total (207 units in US)
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Zambia
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)