Recall Z-1659-2015— Siemens Medical Solutions Diagnostics
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions Diagnostics, initiated 2015-03-05, terminated 2018-01-16. It names one FDA 510(k) clearance: K970277. Product: 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..
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-05
- Terminated
- 2018-01-16
- Firm location
- Flanders, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.