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.
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. 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, Ire Quantity: 725,568 units (Updated) Lot/code info: UDI/DI 15099590229986, Lot Numbers: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, 338538. UPDATED - ADDITIONAL LOT NUMBERS PER EXPANSION EMAIL DATED 10/30/2024: 234600, 234633, 234682, 234706, 234721, 234759, 234790, 234801, 234834, 234862, 337904, 337930, 337935, 337959, 337984, 338040, 338065, 338119, 338163, 338214, 338229, 338254, 338270, 338289, 338322, 338333, 338346, 338420, 338435, 33845, 33848, 338511, 338538, 338566, 338587, 338621, 338622, 338698, 338719, 338720, 338738, 338753, 338762, 338783, 338860, 338996, 339040, 339041, 339056, 339107, 339106, 339146, 439113, 439111, 439157, 439229, 439239, 439285¿.
15099590229986
Official record: FDA (Device enforcement) ↗
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