Device product
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Z-1311-2018
Product summary
- Event
- Event 79462
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47
- Official record key
device-enforcement:Z-1311-2018
Official wording
Reason: Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Code information: Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Distribution pattern: US Distribution in states of: CA, FL and IN.
Derived failure modes
-
Unknown
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.