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.
What this means for you
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
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