FDA Device

Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835

Hazard

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.

What You Should Do

Remedy

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.

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Products

Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
Brand
Beckman Coulter Inc
UPC
Part Number 7547053, Lot Number 754801F

Units Affected

97 units in the US; 37 units Internationally

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