CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report
Water bottles, Catalog#10380062, #10291586. The Immulite recalled
Siemens Medical Solutions Diagnostics is recalling Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1658-2015
- FDA event ID
- 71022
- Recalling firm
- Siemens Medical Solutions Diagnostics, Flanders, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2015
- FDA classified
- 23 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Mar 2015 | Recall initiated by company | |
| 23 May 2015 | Classified by FDA | +79 days |
| 3 Jun 2015 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
(Water Bottle) - Product Code #10380062; Catalog #10291586
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 71022This product is part of a recall event; the main page for the event is Accessory Kit recalled by Siemens Medical Solutions.
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