Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits
Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.
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 the hazard is an incorrect diagnosis, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hycor Biomedical Inc is recalling the HYTEC 288 System, Model 74007P, and associated HYTEC AUTOSTAT II RF assay kits (IgM, IgA, IgG, and Total Rheumatoid Factor). The recall covers all lots of the RF assays. The products were distributed worldwide to the United States (Texas), Netherlands, Belgium, Austria, Italy, and India.
The recall is due to reports that control and negative samples may show elevated results following a sample containing high levels of IgG. This issue can cause negative controls to report out of range or negative samples to be recovered as low positives, which could contribute to an incorrect or premature diagnosis of rheumatoid arthritis.
Healthcare facilities and laboratories using these instruments and kits should stop using the affected products and contact Hycor Biomedical Inc for instructions on returning or replacing the equipment and kits.
The recalled product
- Product
- HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part…
- Manufacturer
- Hycor Biomedical Inc
- Affected units
- 288
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 lots of RF assay
Distribution
Distributed in 1 state:
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