Recall Z-2124-2017— Beckman Coulter Inc.

Name: FDA recall Z-2124-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-24

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-24, terminated 2017-12-30. It names one FDA 510(k) clearance: K082251. Product: Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Reason: Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-24
Terminated: 2017-12-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100Beckman Coulter, Inc.·cleared 2009-04-08

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

Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine

Reason for recall

Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

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