Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
FDA device recall Z-1499-04 · posted 2004-09-30 · Terminated
Recall details
- Recalling firm
- PerkinElmer LAS Inc
- Reason for recall
- There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
- Action taken
- The firm contacted their consignees by letter sent 9/8/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIA
- Quantity affected
- 49 kits
- Distribution
- The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
- Date initiated
- 2004-09-08
- Date posted
- 2004-09-30
- Date terminated
- 2008-10-29
- Location
- Norton, OH
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