CMV IgM EIA Diagnostic Test Recalled for Increased False Positives
Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.
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: This is an FDA Class II medical device recall involving diagnostic inaccuracy. The test produces increased false positive results with no reported patient illnesses or injuries. Per the severity rubric, this represents a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 180 kits of its CMV IgM EIA (Enzyme Immunoassay), an in vitro diagnostic test used to detect cytomegalovirus (CMV) IgM antibodies. The FDA classified this as a Class II recall.
The test kits are being recalled due to an unusual increase in the positivity rate. This means the test is reporting positive results at higher rates than expected, potentially producing false positive results that could lead to incorrect patient diagnoses.
The affected test kits bear catalog number 25178 and lot numbers B02022, E10022, and G05022. These kits were distributed in 14 U.S. states: California, Colorado, Florida, Georgia, Hawaii, Iowa, Massachusetts, Minnesota, North Carolina, New Hampshire, New Jersey, Pennsylvania, Tennessee, and Texas.
The recalled product
- Product
- CMV IgM EIA, in vitro diagnostic.
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Affected units
- 180
Distribution
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