Recall Z-1253-2017— Phadia US Inc

Name: FDA recall Z-1253-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-30

Class II · Terminated

Class II FDA medical device recall by Phadia US Inc, initiated 2017-01-30, terminated 2017-08-07. It names one FDA 510(k) clearance: K061165. Product: EliA Sample Diluent, Article number, 83-1023-01. Reason: 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..

Recalling firm: Phadia US Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-30
Terminated: 2017-08-07
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K061165 — ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01Sweden Diagnostics (Us), Inc.·cleared 2006-08-03

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

EliA Sample Diluent, Article number, 83-1023-01

Reason for recall

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.

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