Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
FDA device recall Z-1127-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Meridian Bioscience Inc
- Reason for recall
- The Low Positive Standard kit component is losing potency that may result in false positive test results.
- Action taken
- The firm notified their customers by telephone and fax on 6/18/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFZ
- Quantity affected
- 43 kits
- Distribution
- The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
- Date initiated
- 2003-06-18
- Date posted
- 2003-08-12
- Date terminated
- 2004-03-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CMV ELISA TEST SYSTEM (K924096) | Zeus Scientific, Inc. | 1993-04-02 |