FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-0028-2012
- Recalling firm
- Beckman Coulter Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-08-12
- Posted
- 2011-10-07
- Terminated
- 2012-04-04
- Reason
- 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
- Root cause
- Mixed-up of materials/components
- Action
- 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.
- Quantity
- 391 units total (193 in US)
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Serial Numbers: 1001008698, 1001008699, and 10018700.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQW
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28