Recall Z-2689-2017
Beckman Coulter Inc. · initiated May 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All serial numbers currently in the field
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2689-2017
- Initiated
- May 22, 2017
- Terminated
- March 31, 2021
- Product code
- PER – Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- Quantity
- 43 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2690-2017 Class II | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used…When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow… | 05/22/2017Terminated |