Recall Z-1376-2024 ยท PPM General Purpose Reagent
Beckman Coulter, Inc.
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
| Date | Mar 25, 2024 (initiated Feb 7, 2024) |
| Status | Open, Classified |
| Reason | 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 re |
| Root 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 Cana |
| Quantity | 725,568 units (Updated) |
| 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, Es |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.