Power Processor 3K, 3K High Speed Stockyards recallZ-0117-2022 · Beckman Coulter Inc. · initiated Jul 28, 2021

Why it was recalled

Missing splash guard which may expose users to hazardous materials. .

FDA root cause category: Process control

What the company is doing

During the week of 08/30/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via its Field Action Notification process. On 09/16/2021, the Recalling Firm communicated a updated/revised "URGENT MEDICAL DEVICE RECALL" Notification letter which informed customer that, as a result of internal investigations, the Recalling Firm has discovered that the track-level splash guard has not been consistently provided to all customers. This guard is required for safe operation of the Power Processor system and could potentially cause user injuries if the splash guard is not in place. Customer are being informed that a Recalling Firm Field Service representative will check their system for the splash guard. if the splash guard is not present, the Field Service representative will order and install it. Customers are instructed to: 1. Continue to follow all safety warnings and system operation information provided in the Instructions for Use. 2. Share this information with their laboratory staff and to retain this notification as part of their laboratory Quality System documentation. 3. If customers have forwarded any of the affected products to another laboratory, provide a copy of this notification to them. 4. To confirm receipt of this Notification, customer are asked to respond within 10 days in one of the following ways: -Electronically, if you received this communication via email. -Manually, complete and return the enclosed Response Form. Any questions, contact the Recalling Firm's Customer Support Center or their local representative via website http://www.beckmancoulter.com Update 12/15/2021: On 12/13/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter informing of additional products being added to the original Recall initiated in 08/2021 for the missing splash guards. A Recalling Firm's Representative will check the systems and if a splash guard is not present, they will order and install it. In addition, the Recalling Firm is a

Recall details

Recall number

Z-0117-2022

Status

Open, Classified

Initiated by the company

Jul 28, 2021

Posted by the FDA

Oct 14, 2021

Recalling firm

Beckman Coulter Inc.

Quantity

Total Units=271 units [258 units (3K and 3K HS); 13 units (5K added 12/15/2021)]

Product code

CDD

FDA submissions

K110413

Distribution

U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA, MI, MS, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WA, and WV O.U.S.: Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, and Taiwan. Additional O.U.S. added 12/15/2021 - South Africa

Product description

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Power Processor Sample Handling System

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  1 recall2 reports

Other devices under the same FDA submission

1 device cleared under K110413 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Power Link

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  1 report