Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits
Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic accuracy (false positives) rather than direct physical injury or a high-risk pathogen, fitting the criteria for moderate severity involving labeling or performance errors without reported physical harm.
Plain-English summary
Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05. This product is an enzyme-linked immunosorbent assay (ELISA) method intended for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The test is used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations.
The recall was initiated due to reports of a higher than anticipated positivity rate for patients tested using the IgM Kit. This issue means that some negative samples may be incorrectly reported as positive for IgM antibodies to Rheumatoid Factor. The affected lot number is 154962.
The product was distributed in the United States (Texas) and in foreign countries including the Netherlands, Belgium, Austria, Italy, and India. Consumers and healthcare providers should stop using the affected test kits and contact Hycor Biomedical Inc for further instructions or a replacement.
The recalled product
- Product
- AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determina
- Manufacturer
- Hycor Biomedical Inc
- Affected units
- 207
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)
- Lot Number 154962
Distribution
Distributed in 1 state:
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