Hycor recalls HYTEC 288 System Model 74007P automated immunoanalyzer for potential incorrect rheumatoid factor test results due to elevated readings in high IgG samples.
Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
Hycor is recalling its HYTEC 288 System Model 74007P automated immunoanalyzer because it may give incorrect rheumatoid factor test results when samples contain high levels of IgG. This could lead to premature or wrong diagnoses of rheumatoid conditions.
The instrument may show elevated readings in samples with high IgG levels, causing the negative control to report out of range and potentially misclassifying negative samples as low positives. This could lead to incorrect rheumatoid factor diagnoses.
Healthcare providers using the HYTEC 288 System Model 74007P for rheumatoid factor testing with specific kits may be affected. Patients receiving these tests could be at risk of incorrect diagnoses.
Check for the HYTEC 288 System Model 74007P with specific Rheumatoid Factor test kits (FGA 05, FGA 06, FGA 07, FGA 08) used in the instrument. The recall covers all lots of these RF assay kits.
Verify if you have the HYTEC AUTOSTAT II RF IgM, IgA, IgG, or Total Rheumatoid Factor test kits with part numbers FGA 05 through FGA 08.
The HYTEC 288 System may show elevated readings in samples with high IgG levels, potentially causing negative controls to report out of range and misclassifying samples.
The affected test kits are HYTEC AUTOSTAT II RF IgM (FGA 05), IgA (FGA 06), IgG (FGA 07), and Total Rheumatoid Factor (FGA 08).
No, the recall does not require stopping use of the instrument. The issue affects specific test kits, not the entire system.
We’ve drafted a message you can send Hycor to request your refund or repair — edit it as you like.
Subject: Recall Z-2200-2019 — Hycor Hycor Hello, I own a Hycor that is covered by recall Z-2200-2019 from Hycor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
