Coulter DxH Diluent recall
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The…
Why was Coulter DxH Diluent recalled?
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
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. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.
- Product
- Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 46,050 units total (40,078 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
- Recall date
- September 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)