ClearanceBrief
Recall Z-0879-05 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Perkin Elmer Life And Analytical

Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit

DateJun 9, 2005 (initiated Mar 11, 2005)
StatusTerminated
ReasonPump failure may effect data integrity
Root causeOther
ActionPerkin Elmer notified US Customers by letter on 3/11/05. Instructions were provided to service engineers for preventative maintenance. During the week of 5/5/05, the firm is issuing a recall letter recalling the solvents and solutions of these kits. The firm will send a Service Engineer to oversee destruction and maintenance of the pump.
Quantity622 kits
DistributionAL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR,SC
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.