Medical Device Recall: Z-0028-2012

FDA Recalls dataset · Firm: Beckman Coulter Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-08-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2012.

Recall Res Number
Z-0028-2012
Recalling Firm / Manufacturer
Beckman Coulter Inc.
FEI Number
2050012
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-08-12
Date Posted
2011-10-07
Date Terminated
2012-04-04
Product Code
JQW
Event Number
59535
Product Quantity
391 units total (193 in US)
Product Description Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Reason for Recall The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen
Action Details Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter Representative.
Distribution Pattern Worldwide distribution.
Code Information / Serial Numbers Serial Numbers: 1001008698, 1001008699, and 10018700.

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.