AQUIOS CL Flow Cytometer recall
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is…
Why was AQUIOS CL Flow Cytometer recalled?
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
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 existing software versions (2.0, 2.0.1, and 2.1).
- Product
- AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 268 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
- Recall date
- November 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)