Phadia Recalls EliA Sample Diluent Due to Liquid Level Detection Issues
Phadia US Inc is recalling EliA Sample Diluent because liquid level detection problems in Phadia 250 instruments caused erroneous test results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that produces erroneous test results, which poses a risk of harm to patients through incorrect diagnosis or treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Phadia US Inc is recalling EliA Sample Diluent, Article number 83-1023-01. The recall involves 5,957 units distributed across 26 U.S. states. The affected lots are JM3Y, JS0B, JP87, JK5N, and JU9C.
The recall was initiated due to erroneous EliA test results. An investigation identified problems with liquid level detection in diluent bottle batch JJCA, which resulted in the aspiration of no or too low volumes of liquid from the diluent bottle and the dilution plate. Deformed bottles were also noted in the context of the instrument issues.
Users of the affected product should stop using the EliA Sample Diluent and contact Phadia US Inc for further instructions or a replacement.
The recalled product
- Product
- EliA Sample Diluent, Article number, 83-1023-01
- Manufacturer
- Phadia US Inc
- Affected units
- 5,957
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 (8)
- EliA Sample Diluent
- Article number
- 83-1023-01
- lots JM3Y
- JS0B
- JP87
- JK5N
- and JU9C
Distribution
Related recalls
Same manufacturer · Phadia US Inc
See all →- ModeratePhadia 2500EE diagnostic instrument recalled for measurement inaccuracy
FDA (Devices) · 2023-07-05
- ModerateDiagnostic Test Well Shows Inconsistent Results on Phadia 2500EE
FDA (Devices) · 2023-07-05
- ModeratePhadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
FDA (Devices) · 2021-02-17
- ModeratePhadia Recalls ImmunoCAP Allergen c5 Ampicilloyl Test Kits
FDA (Devices) · 2018-04-11
- ModeratePhadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures
FDA (Devices) · 2018-04-11
Same hazard · erroneous test results
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighVITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
FDA (Devices) · 2025-07-09
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing
FDA (Devices) · 2024-03-13
Similar recalls
- ModeratePhadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
FDA (Devices) · 2021-02-17
- ModeratePhadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error
FDA (Devices) · 2019-09-04
- ModeratePhadia Recalls EliA SmDP Wells Due to Invalid Test Results
FDA (Devices) · 2016-02-03
- HighEliA GBM Diagnostic Wells Recalled for False Positive Results
FDA (Devices) · 2024-01-31
- HighPhadia 1000 Instrument Recalled Due to Retry Command Malfunction
FDA (Devices) · 2018-01-24
- ModeratePhadia 1000 Instrument Recalled for Rack Sequencing Error
FDA (Devices) · 2015-01-21