Recall Z-1876-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
CYTO-STAT tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD
| Date | Apr 4, 2011 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionality. |
| Root cause | Pending |
| Action | An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions: ACTION/RESOLUTION For issue 1: The specimen stability claims should be as follows: - 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube - 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames prov |
| Quantity | 78,988 units |
| Distribution | Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030408 | CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A Beckman Coulter, Inc., Mar 4, 2003 |