Z-0002-2013Class II

COULTER PrepPlus, Part Number: 286600

Name: Z-0002-2013 COULTER PrepPlus, Part Number: 286600
Creator: Beckman Coulter Inc.
Published: 2012-01-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-01-20 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for... on 2012-01-20. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0002-2013
Classification: Class II
Status: Terminated
Initiated: 2012-01-20
Posted: 2012-10-01
Terminated: 2012-10-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, 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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent an Urgent Product Correction letter dated January 20, 2012 to all their customers who purchased the affected product. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to complete and return the Response Form with in 10 days. Customers with questions regarding the PCA letter were instructed to contact Beckman Coulter Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter Representative.
Quantity in commerce: 36 units total (15 units in the US)
Distribution: Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-01

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)