Device Recall FlowCount Fluorospheres 의 리콜

Recall

45918

Class 2

Z-0525-2008

2007-05-21

2008-02-06

Terminated

United States

2012-10-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66482

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.

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 replacement. If no evidence of deterioration has been observed, the firm states that there should not be any negative impact to the results obtained. A response form is included and should be returned to the firm within 10 days. Questions regarding this recall can be addressed by contacting Beckman Coulter Customer Service at 1-800-526-7694.