Reported Apr 3, 2024 · Ongoing
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Access Substrate, REF 81906, For use with the Access Immunoassay Systems
- Lot codes and dates
- UDI/DI 15099590229986
- Lot Numbers
234600337984338040338214338229338289338322338333338451338587338538. UPDATED - ADDITIONAL LOT NUMBERS
- PER EXPANSION EMAIL DATED 10/30/2024
2346002346332346822347062347212347592347902348012348342348623379043379303379353379593379843380403380653381193381633382143382293382543382703382893383223383333383463384203384353384533848338511338538338566338587338621338622338698338719338720338738338753338762338783338860338996339040339041339056339107339106339146439113439111439157439229439239439285¿
- Amount recalled
- 725,568 units (Updated)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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