Z-1311-2018 Class II Terminated
FDA device recall Z-1311-2018 was initiated by Roche Diagnostics Corporation on Dec 22, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Apr 5, 2019). Affected quantity: 47.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 11, 2018
- Initiation Date
- Dec 22, 2017
- Termination Date
- Apr 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47
Product Description
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Reason for Recall
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.
Distribution Pattern
US Distribution in states of: CA, FL and IN.
Code Information
Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1311-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026