Siemens Medical Solutions Recalls IMMULITE 2000 and VersaCell Diagnostic Instruments
Siemens Medical Solutions Diagnostics is recalling 1,006 IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems due to a potential for incorrect test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of incorrect diagnostic results, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling 1,006 units of IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems. These are continuous random-access instruments and robotic sample-moving devices used for in vitro diagnostic testing on serum, plasma, or urine samples. The recall is due to a potential for incorrect results to be reported from the processing of a sample tube.
The affected units were distributed nationwide and to foreign locations. Specific model codes for the IMMULITE 2000 include 10380062, 10380061, 10380079, 10380065, 10360210, and 10283632. The IMMULITE 2000XPi is identified by code P010053/S007 and 10373214. VersaCell units are identified by codes 10380063, 10389945, 10380064, 10287115, and 10793839.
The U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the recall is intended to prevent the reporting of incorrect diagnostic results.
The recalled product
- Product
- 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 sa
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Hazard
- Affected units
- 1,006
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- IMMULITE 2000: 10380062
- 10380061
- 10380079
- 10380065
- 10360210
- 10283632 IMMULITE 2000XPi: P010053/S007
- 10373214 VersaCell: 10380063
- 10389945
- 10380064
- 10287115
- 10793839
Distribution
Distributed nationwide across the United States.
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