Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

COULTER PrepPlus, Part Number: 286600

FDA Recall Z-1758-2010 · Posted 2010-06-04

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQW
Date Initiated2010-01-21
Date Terminated2012-04-04
Product Quantity193 units in total

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

Firm 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.

Root Cause

Other

Distribution Pattern

Domestically and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑