Recall Z-1107-2017— PerkinElmer Life and Analytical Sciences, Wallac, OY

Name: FDA recall Z-1107-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-05

Class II · Terminated

Class II FDA medical device recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, initiated 2017-01-05, terminated 2017-08-24. It names one FDA 510(k) clearance: K090846. Product: Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.. Reason: The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells..

Recalling firm: PerkinElmer Life and Analytical Sciences, Wallac, OY
Classification: Class II
Status: Terminated
Initiated: 2017-01-05
Terminated: 2017-08-24
Firm location: Turku, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K090846 — GSP INSTRUMENT AND GSP NEONATAL HTSH KITPerkinelmer, Inc.·cleared 2009-09-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

Reason for recall

The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.

Data sourced from openFDA. This site is unofficial and independent of the FDA.