DxH 600 Coulter Cellular Analysis System recall
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Why was DxH 600 Coulter Cellular Analysis System recalled?
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
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?
Serial Numbers: All
- Product
- DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 1,282 units total (915 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)