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

Recall number

Z-0117-2022

Recalling firm

Beckman Coulter Inc.

Product

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

Status

Open, Classified

Initiated

2021-07-28

Posted

2021-10-14

Terminated

not on file

Reason

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

Root cause

Process control

Action

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

Quantity

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

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

Lot, serial or model codes

Catalog Number: A88116 - 3K HS Refrigerated Stockyard UDI: 15099590591960 Serial Numbers: 90HF1304006; 90HF1306009; 90HF1303005; 90HF1508005; 90HF1302005; 90HF1610005; 90HF1806001; 90HF1209005; 90HF1303007; 90HF1708006; 90HF1205001; 90HF1805002; 90HF1402005; 90HF1503001; 90HF1104002; 90HF1208004; 90HF1208005; 90HF1203001; 90HF1012004; 90HF1101002; 90HF1702003; 90HF1402004; 90HF1303008; 90HF1210001; 90HF1207001; 90HF1305007; 90HF1305004; 90HF1610001; 90HF1505002; 90HF1307005; 90HF1610002; 90HF1508003; 90HF1210002; 90HF1306001; 90HF1206002; 90HF1208002; 90HF1305008; 90HF1009002; 90HF1101001; Catalog Number: 6915556 - Power Processor 3K Stockyard (Stockyard 3000/R Kit for PWR PROC) Serial Numbers: 90AM0805001; 90AM0902009; 90AM0902005; 90AM0806003; 90AM0801003; 90AM0802002; 90AM0803001; 90AM0912002; 90AM1003002; 90AM0905010; 90AM0801004; 90AM06007008; 90AM060703; 90AM060704; 90AM0710002; 90AM0905007; 90AM0710008; 90AM0903002; 90AM0808002; 90AM0711004; 90AM0711005; 90AM0810001; 90AM0901002; 90AM0905006; 90AM0904004; 90AM0904005; 90AM0803002; 90AM0710004; Amended - additional Products and Codes (12/15/2021): B05520 - Stockyard, 5K HS, Refrigerated Serial Numbers: 90HG1104002; 90HG1101001; 90HG1105002; 90HG1104001; 90HG1101003; 90HG1101002; 90HG1202004; 90HG1102005; 90HG1101004; 90HG1206002; A88115 - 5K HS Refrig Stockyard Serial Numbers: 90HG0911001 90HG0911003 90HG0911002

510(k) numbers

["K110413"]

PMA numbers

not on file

Product code

CDD

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

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

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