Access Substrate Reagent Bottles Recalled for Missing Product Labels
Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The source explicitly states the missing label will not cause erroneous results and the probability of harm is remote. This constitutes a minor labeling error meeting the Moderate severity criteria.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Substrate bottles (REF 81906), a reagent used with Access Immunoassay Systems, due to missing product labels on affected manufacturing lots. The bottles were released from manufacturing without labels, which may cause delays in patient result reporting.
While the missing labels may delay result reporting, Beckman Coulter and the FDA note that the defect will not cause erroneous or incorrect test results. Because clinical laboratories are required to have redundancy measures that prevent delays from significantly impacting patient care, and because the missing labels are easily recognized by laboratory staff, the probability of patient harm is considered remote.
The recall affects units distributed nationwide in the United States and to numerous countries worldwide. Laboratories using affected lots should contact Beckman Coulter for replacement product.
The recalled product
- Product
- Access Substrate, REF 81906, For use with the Access Immunoassay Systems
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- missing-label
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 15099590229986
- Lot Numbers: 234600
- 337984
- 338040
- 338214
- 338229
- 338289
- 338322
- 338333
- 338451
- 338587
- 234633
- 234682
- 234706
- 234721
- 234759
- 234790
- 234801
- 234834
- 234862
Distribution
Distributed nationwide across the United States.
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