Recall Z-0646-2017— Lsi Medience Corporation

Name: FDA recall Z-0646-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-16

Class II · Terminated

Class II FDA medical device recall by Lsi Medience Corporation, initiated 2016-08-16, terminated 2017-02-27. It names one FDA 510(k) clearance: K072288. Product: Pathfast D-Dimer, Reference number: PF1051-KUS. Reason: Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product..

Recalling firm: Lsi Medience Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-08-16
Terminated: 2017-02-27
Firm location: Tokyo, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K072288 — PATHFAST D-DIMERMitsubishi Kagaku Iatron·cleared 2009-05-06

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

Pathfast D-Dimer, Reference number: PF1051-KUS

Reason for recall

Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

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