Recalls / —

—#189093

Product

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

FDA product code

CDD — Radioassay, Vitamin B12

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K110413

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Beckman Coulter Inc.

Address

250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern

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

Timeline

Recall initiated

2021-07-28

Posted by FDA

2021-10-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189093. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.