Food, drugs, devices › Siemens Medical Solutions Diagnostics
Device recall: Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instrume
FDA enforcement event 71022 is a device recall by Siemens Medical Solutions Diagnostics of Flanders, NJ, initiated 5 Mar 2015 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 16 Jan 2018. Initiation: voluntary: firm initiated. Siemens Medical Solutions Diagnostics has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions Diagnostics, Flanders, NJ.
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."
Distribution
"Worldwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1658-2015 | Water bottles, Catalog#10380062, #10291586. 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. | 186 bottles | Class II | Terminated | 3 Jun 2015 |
| Z-1659-2015 | 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. | 231 bottles | Class II | Terminated | 3 Jun 2015 |
| Z-1660-2015 | Accessory Kit, Catalog#10282965, #10373217,#10286080. 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. | 962 bottles | Class II | Terminated | 3 Jun 2015 |
| Z-1661-2015 | Direct Water feed Kit, Catalog#10373222 | 15 bottles | Class II | Terminated | 3 Jun 2015 |
| Z-1662-2015 | Water Feed Kit, Catalog#10288216,#10389714. 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. | 8 bottles | Class II | Terminated | 3 Jun 2015 |
| 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. | 15 bottles | Class II | Terminated | 3 Jun 2015 |
Context
Other enforcement events for Siemens Medical Solutions Diagnostics
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Apr 2014 | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to | Device | Class III | 1 |
| 3 Feb 2014 | IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perfo | Device | Class II | 1 |
All 3 events for Siemens Medical Solutions Diagnostics
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jan 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.