Recall Z-0117-2022 ยท CDD Radioassay, Vitamin B12
Beckman Coulter Inc.
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
| Date | Oct 14, 2021 (initiated Jul 28, 2021) |
| Status | Open, Classified |
| 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 pla |
| 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, Thai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS Beckman Coulter, Inc., May 11, 2011 |