TetraCXP Software System recall: Software Issue
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual…
Why was TetraCXP Software System recalled?
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping
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 tetraCHROME lots manufactured
- Product
- TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 146 units total (37 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay
- Recall date
- October 17, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)