Retiro De Equipo (Recall) de Device Recall EliA Sample Diluent, Article number, 83102301

Recall

76343

Class 2

Z-1253-2017

2017-01-30

2017-02-24

Terminated

United States

2017-08-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152965

Erroneous elia test results related to problems with liquid level detection and diluent pipetting in phadia 250 instruments, and deformed bottles. investigation showed problems with the liquid level detection in diluent bottle batch jjca resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.

Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: ¿ Stop using the affected lots of the above mentioned product lots ¿ Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. ¿ Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. ¿ Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.