FDA Recall
Terminated
Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Recall: Z-1659-2015
·
Initiated March 5, 2015
Recall
- Recall Number
- Z-1659-2015
- Event Number
- 71022
- Firm
- Siemens Medical Solutions Diagnostics
- FEI Number
- 1000122204
- Product Code
- JJE
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 5, 2015
- Posted
- May 23, 2015
- Terminated
- January 16, 2018
- Address
- 62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715
Description
Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Reason
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Action
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
Distribution
Worldwide Distribution.
Quantity
231 bottles