The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam
FDA device recall Z-0541-05 · posted 2005-02-15 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LHL
- Quantity affected
- 178
- Distribution
- Distributed to Domestic customers only.
- Date initiated
- 2004-12-23
- Date posted
- 2005-02-15
- Date terminated
- 2012-05-03
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEGIONELLA ELISA TEST SYSTEM (K970149) | Zeus Scientific, Inc. | 1997-06-18 |