FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
- Recall number
- Z-0525-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
- Status
- Terminated
- Initiated
- 2007-05-21
- Posted
- 2008-02-06
- Terminated
- 2012-10-15
- 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 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.
- 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 control.***
- Lot, serial or model codes
- Part Number 7547053, Lot Number 754801F
- 510(k) numbers
- ["K954688"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28