—#53495

Product

FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Number 624922. Software versions 1.1 & 1.2

Why it was recalled

Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.

Timeline

Recall initiated: 2007-02-22
Posted by FDA: 2007-10-16
Terminated: 2012-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.