Class 2 Device Recall Beckman Coulter Access Substrate

• Date Initiated by Firm: February 07, 2024
• Date Posted: March 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1376-2024
• Recall Event ID: 94123
• Product Classification: General purpose reagent - Product Code PPM
• Product: Access Substrate, REF 81906, For use with the Access Immunoassay Systems
• Code Information: UDI/DI 15099590229986, Lot Numbers: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, 338538
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Rachel Davison; 714-993-5321
• Manufacturer Reason for Recall: On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.
• FDA Determined Cause: Under Investigation by firm
• Action: Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" NOTICE dated 2/14/2024 to its consignees on via USPS and email. The notice explained the issue, impact, and actions to be taken. The consignees were requested to verify upon receipt that all Access substrate bottle have a label. It further directed the discard of all those without labels, Contact your Beckman Coulter representative and request a replacement order for bottles missing labels. If you have an questions regarding this notice, please contact Beckman Coulter by telephone at: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative. From website: http://www.beckmancoulter.com
• Quantity in Commerce: 151,730 units
• Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen, Zambia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.