Water Feed Kit, Catalog#10288216,#10389714 recallZ-1662-2015 · Siemens Medical Solutions Diagnostics · initiated Mar 5, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
Recall details
- Recall number
- Z-1662-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 5, 2015
- Posted by the FDA
- May 23, 2015
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Quantity
- 8 bottles
- Product code
- JJE
- FDA submissions
- K970227, P010053S007
- Distribution
- Worldwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Water Feed Kit - Product Code/Catalog #'s 10288216 and 10389714
Other devices under the same FDA submission
3 devices cleared under K970227, P010053S007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE® 2000 XPi Immunoassay System 10373214Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE286 reports
- VersaCell® X3 10793839Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE3 reports
- IMMULITE® 2000 Systems TSH Third Generation TSH 10381665Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 71022).
- Z-1658-2015 · TerminatedWater bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instr…
- Z-1660-2015 · TerminatedAccessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instrume…
- Z-1661-2015 · TerminatedDirect Water feed Kit, Catalog#10373222
- Z-1663-2015 · TerminatedLiquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instru…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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