Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
This recall has been terminated (originally issued February 28, 2012).
- Recall Initiated
- January 9, 2012
- Posted
- February 28, 2012
- Terminated
- March 6, 2013
- Recall Number
- Z-1116-2012
- Quantity
- 10 units
- Firm Location
- Turku Finland
- Official Source
- View on FDA website ↗
Reason for Recall
GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
Distribution
Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
Lot / Code Info
Serial numbers from 20210012 to 20210021
Root Cause
Nonconforming Material/Component
Action Taken
Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.