The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
This recall has been terminated (originally issued February 15, 2005).
- Company
- Diamedix Corporation
- Recall Initiated
- December 23, 2004
- Posted
- February 15, 2005
- Terminated
- May 3, 2012
- Recall Number
- Z-0541-05
- Quantity
- 178
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed to Domestic customers only.
Lot / Code Info
Lot # 91803Z and 30804/30804Z
Root Cause
Other
Action Taken
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.
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