Coulter DxH Cleaner 10L recall: Impurity Out of Spec
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
Why was Coulter DxH Cleaner 10L recalled?
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
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?
Lot No. 3040210 3040330 3043090 3043100 3057970 3057980 3058130 3071440 3071450
- Product
- Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 12,924 units total (9,733 units in US)
- Distribution
- Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)