Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1663-2015 — Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

U.S. FDA — Device Enforcement · United States · 2015-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1663-2015
Date of alert
2015-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10386287
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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