Z-2136-2018 Class II Terminated
FDA device recall Z-2136-2018 was initiated by Roche Diagnostics Corporation on April 3, 2018 and is designated Class II. Reason for recall: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe fun… The recall status is terminated (terminated November 21, 2019). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- April 3, 2018
- Termination Date
- November 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Reason for Recall
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Distribution Pattern
US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
Code Information
Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02