Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
FDA Recall Z-1116-2012 · Posted 2012-02-28
Recalling FirmPerkinElmer Life and Analytical Sciences, Wallac, OY
Recall StatusTerminated
Product CodeKHO
Date Initiated2012-01-09
Date Terminated2013-03-06
Product Quantity10 units
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.