Hycor recalls AUTOSTAT II IgM Rheumatoid Factor test kits due to potential false positive results for Rheumatoid Factor. This may lead to incorrect diagnoses of Rheumatoid Arthritis. Affected kits have lot number 154962.
Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.
Hycor is recalling AUTOSTAT II IgM Rheumatoid Factor test kits because they may show false positive results for Rheumatoid Factor. This could lead to incorrect diagnoses of Rheumatoid Arthritis. The recall affects kits with lot number 154962.
The test kits may report negative samples as positive for Rheumatoid Factor antibodies. This could lead to incorrect diagnoses of Rheumatoid Arthritis if used without proper clinical context. The false positives are not expected to cause physical harm but may lead to unnecessary medical procedures.
People who use the AUTOSTAT II IgM Rheumatoid Factor test kits for Rheumatoid Arthritis diagnosis may be affected. Those with Rheumatoid Arthritis who rely on these tests for diagnosis are at higher risk.
Check for the lot number 154962 on the test kit packaging. The product is labeled as AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05.
Look for lot number 154962 on the test kit packaging to confirm if it is affected.
The test kits may show false positive results for Rheumatoid Factor, which could lead to incorrect diagnoses of Rheumatoid Arthritis.
Check the lot number on the packaging. If it is 154962, contact Hycor for further instructions.
No, the recall is for potential false positives that could lead to incorrect diagnoses, not physical harm.
We’ve drafted a message you can send Hycor to request your refund or repair — edit it as you like.
Subject: Recall Z-2134-2019 — Hycor Hycor Hello, I own a Hycor that is covered by recall Z-2134-2019 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.
