Z-0117-2022Class II

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

Name: Z-0117-2022 Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Creator: Beckman Coulter Inc.
Published: 2021-07-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-07-28 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116 on 2021-07-28. FDA classified it as Class II and gives the reason as "Missing splash guard which may expose users to hazardous materials". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0117-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-28
Posted: 2021-10-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Product code: CDD Radioassay, Vitamin B12
Reason for recall: Missing splash guard which may expose users to hazardous materials. .
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0117-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-14

Product code CDD

K110413Class IIPower Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. / cleared 2011-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)