EliA GBM Diagnostic Wells Recalled for False Positive Results
Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.
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: This is an FDA Class II recall of a diagnostic medical device without reported illnesses or injuries. The false positive results pose a risk of diagnostic inaccuracy and potential patient harm, meeting the criterion for a High severity rating.
Plain-English summary
Phadia Ab is recalling EliA GBM Wells (Material Number 14551401), which are components of Phadia 250, 2500, and 5000 in vitro diagnostic analyzers. Approximately 124,928 kits are affected and were distributed throughout the United States.
The recall was initiated following complaints that specific samples produced false positive results in EliA GBM testing. Investigation revealed that these wells exhibited unexpected coating-solution reactivity, generating a positive signal when samples without antigen were tested. This indicates the wells are producing false positive diagnostic results.
Affected customers should contact Phadia Ab for return or replacement instructions.
The recalled product
- Product
- EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
- Manufacturer
- Phadia Ab
- Hazard
- Affected units
- 124,928
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 (2)
- UDI-DI: 07333066010670
- All Lots.
Distribution
Distributed nationwide across the United States.
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