Recall Z-1116-2012 ยท KHO Fluorometer, For Clinical Use
PerkinElmer Life and Analytical Sciences, Wallac, OY
Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
| Date | Feb 28, 2012 (initiated Jan 9, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 10 units |
| Distribution | Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT Perkinelmer, Inc., Sep 3, 2009 |