Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results
Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to potential false abnormal results, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling 925 units of IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Product Number 447070. The recall affects Lot numbers M012376 and M101865. These products were distributed nationwide in the United States and in Canada.
The recall was initiated after Beckman Coulter confirmed customer reports of quality control shifts, lot-to-lot variation, and an increase in the percentage of patient samples recovering greater than 20 IU/mL. The company determined that the identified lots might produce false abnormal results when used in conjunction with the Beckman Cal 5 Plus system for quantitative determination of human rheumatoid factor concentrations.
Healthcare facilities and laboratories that possess these specific lots should stop using the reagent and contact Beckman Coulter for instructions on return or replacement. The source text does not specify a deadline or additional consumer actions beyond the recall notification.
The recalled product
- Product
- IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 925
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 (1)
- Lot# M012376 and M101865
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · false results
See all →- HighOvulation test devices recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighMenopause test cassettes recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighUrinalysis test strips recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighVaginal pH tests recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
- HighTyphoid antigen tests recalled over missing FDA premarket clearance
FDA (Devices) · 2026-02-11
Similar recalls
- HighBeckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure
FDA (Devices) · 2024-10-23
- HighBeckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings
FDA (Devices) · 2024-07-31
- HighBeckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures
FDA (Devices) · 2020-06-03
- ModerateBeckman Coulter Recalls UIBC Reagent Lot 2690 Due to Erroneous Results
FDA (Devices) · 2020-10-07
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Interference from Specific Drugs
FDA (Devices) · 2017-05-24
- HighBeckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk
FDA (Devices) · 2021-08-18