Phadia 1000 Instrument Recalled Due to Retry Command Malfunction
Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Phadia US Inc is recalling 70 units of the Phadia 1000 Instrument, Article Number 12-3800-01, distributed nationwide. The recall covers all versions of the instrument.
The recall was initiated because the "Retry" command does not function properly. This malfunction could cause a shortage of Wash and Rinse solution, which may affect assay performance and test results.
No specific instructions for consumers are provided in the source text. Users of the affected instruments should contact the recalling firm for further guidance.
The recalled product
- Product
- Phadia 1000 Instrument, Article Number 12-3800-01.
- Manufacturer
- Phadia US Inc
- Hazard
- Affected units
- 70
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)
- All versions of the instrument
Distribution
Distributed nationwide across the United States.
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