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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 725,568
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.
Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
Same hazard · missing label
See all →- LowLevocarnitine Injection USP Missing Label Recall
FDA (Drugs) · 2026-05-06
- HighGreenpower Recalls School Buses Due to Missing Mirror Warning Label
NHTSA · 2026-04-06
- LowCT pendant upgrades recalled for missing a safe hand position label
FDA (Devices) · 2026-01-21
- LowCT pendant replacement kits recalled for missing a safe hand position label
FDA (Devices) · 2026-01-21
- LowMammography systems recalled over a missing or incorrect X-ray warning label
FDA (Devices) · 2025-12-17
Similar recalls
- LowBeckman Coulter Access 2 Immunoassay System Recalled for Burn Risk
FDA (Devices) · 2018-01-10
- ModerateBeckman Coulter Recalls Access Immunoassay Reaction Vessels Due to Motion Errors
FDA (Devices) · 2013-12-25
- ModerateBeckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures
FDA (Devices) · 2025-02-12
- ModerateBeckman Coulter Access Immunoassay System Recalled for Defective Belt Pulley
FDA (Devices) · 2013-04-10
- ModerateBeckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs
FDA (Devices) · 2015-09-09
- ModerateBeckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect
FDA (Devices) · 2017-04-12