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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Access Substrate

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  Class 2 Device Recall Beckman Coulter Access Substrate see related information
Date Initiated by Firm February 07, 2024
Date Posted March 25, 2024
Recall Status1 Open3, 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/
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information Contact Rachel Davison
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 2
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.