Z-2690-2017Class II

Coulter PrepPlus 2, Part Number 378600

Name: Z-2690-2017 Coulter PrepPlus 2, Part Number 378600
Creator: Beckman Coulter Inc.
Published: 2017-05-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-05-22 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to... on 2017-05-22. FDA classified it as Class II and gives the reason as "When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2690-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-07-07
Terminated: 2021-03-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 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.
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Reason for recall: When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres. 2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coulter also requested the consignee share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If the consignee forwarded any of the affected product(s) listed above to another laboratory, They were asked to provide them a copy of the letter.
Quantity in commerce: 473 units
Distribution: Worldwide Distribution
Product codes and lots: All serial numbers currently in the field

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2690-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2689-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-06
Z-2690-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-06

Product code PER

K130253Class ITq-Prep Workstation, Prepplus 2 WorkstationBeckman Coulter, Inc. / cleared 2013-07-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)