Diamedix Corporation The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
Brand
Diamedix Corporation
Lot Codes / Batch Numbers
Lot # 91803Z and 30804/30804Z
Products Sold
Lot # 91803Z and 30804/30804Z
Diamedix Corporation is recalling The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components s due to The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.
Recommended Action
Per FDA guidance
Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026