Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0879-05

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

Perkin Elmer Life and Analytical / initiated 2005-03-11 / Terminated

Perkin Elmer Life And Analytical began a recall of Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit on . The reason FDA records is "Pump failure may effect data integrity". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0879-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Perkin Elmer Life and Analytical
Product
Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
Product code
NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Reason for recall
Pump failure may effect data integrity
FDA root cause
Other
Action
Perkin 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.
Quantity in commerce
622 kits
Distribution
AL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR,SC
Product codes and lots
Catalog Number: MS-8970 Lot numbers: 252208, 257031, 258928, 258937, 259588, 263097, 267166 , 267628, 268256, 268258, 268403, 268404, 268675