CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Immulite 2000; Immulite 2000XPi; VersaCell The Immulite 2000 systems recalled
Siemens Medical Solutions Diagnostics is recalling Immulite 2000; Immulite 2000XPi; VersaCell The Immulite 2000 systems, distributed nationwide in the US. The recall was initiated on 3 Feb 2014 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-1316-2014
- FDA event ID
- 67586
- Recalling firm
- Siemens Medical Solutions Diagnostics, Flanders, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2014
- FDA classified
- 2 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Feb 2014 | Recall initiated by company | |
| 2 Apr 2014 | Classified by FDA | +58 days |
| 9 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for incorrect results to be reported from processing of a sample tube.
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
IMMULITE 2000; IMMULITE 2000XPi; VersaCell 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. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Where it was distributed
Nationwide and Foreign Distribution.
Questions about this recall
Why was it recalled?
There is a potential for incorrect results to be reported from processing of a sample tube.
Which lots are affected?
IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839
Where was it sold?
Nationwide and Foreign 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.
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