Date Initiated by Firm | January 21, 2010 |
Date Posted | June 04, 2010 |
Recall Status1 |
Terminated 3 on April 04, 2012 |
Recall Number | Z-1758-2010 |
Recall Event ID |
55166 |
Product Classification |
Station, pipetting and diluting, for clinical use - Product Code JQW
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Product | COULTER PrepPlus, Part Number: 286600 |
Code Information |
All Serial Numbers are affected. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
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For Additional Information Contact | Clair K. ODonovan, Ph.D. 714-961-4483 |
Manufacturer Reason for Recall | The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials loaded onto the Preppies or PrepPlus 2 systems. Affected systems have a syringe pump with part number A46748 (see illustrations below) which cause the probe to prematurely dispense Isoflow prior to arriving at the wash station.
This condition only occurs with worklist panels which include both |
FDA Determined Cause 2 | Other |
Action | A Product Corrective Action (PCA) letter with attached PCA Response Form was sent on the week of January 25, 2010 to all customers who purchased the pipetting and diluting system: COULTER PrepPlus, or COULTER PrepPlus 2. The letter provides the customers with an explanation of the problem identified and an instruction on proper placing antibody reagent when using a worklist panel which involves both blood specimens and antibody reagents. Customers were also instructed to complete and return the PCA Response Form in addition to sharing the information contained in the PCA with their laboratory staff.
If consignees had any questions they were told to contact their local Beckman Coulter Representative. Questions can be directed to the company's Customer Service office at (800) 526-7694. |
Quantity in Commerce | 193 units in total |
Distribution | Domestically and Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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