Device product
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Z-0181-2014
Product summary
- Event
- Event 66267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4963
- Official record key
device-enforcement:Z-0181-2014
Official wording
Reason: Imprecision with certain lots
Code information: Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
Distribution pattern: Worldwide Distribution - USA (nationwide) and Mexico.
Derived failure modes
-
Unknown
Imprecision with certain lots