Beckman Coulter Inc FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Number 624922. Software versions 1.1 & 1.2
Products Sold
Part Number 624922. Software versions 1.1 & 1.2
Beckman Coulter Inc is recalling FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnos due to Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
Recommended Action
Per FDA guidance
A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026