Recall Z-0525-2008 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
| Date | Feb 6, 2008 (initiated May 21, 2007) |
| Status | Terminated |
| Reason | Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert. |
| Root cause | Process design |
| Action | A Product Corrective Action (PCA) letter was mailed on May 21, 2007, to all accounts that have ordered Flow-Count Fluorospheres, Part Number 7547053, Lot # 754801F. The letter advised that Beckman Coulter has confirmed absolute count recovery failures with assayed control cell products. Additionally, internal testing has indicated secondary fluorescent populations slightly above their indicated 20% of the total population as stated in the Evidence of Deterioration section of the Package Insert. The letter requests that users immediately discard any bottles of the product and call for a repla |
| Quantity | 97 units in the US; 37 units Internationally |
| Distribution | Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954688 | FLOW-COUNT COULTER FLUOROSPHERES Coulter Corp., Feb 29, 1996 |