Recall Z-2084-2017— Beckman Coulter Inc.

Name: FDA recall Z-2084-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-03

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-03, terminated 2018-05-31. It names one FDA 510(k) clearance: K014173. Product: Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.. Reason: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Terminated: 2018-05-31
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.·cleared 2002-02-15

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

Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

Reason for recall

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

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