Recall Z-0309-2018— Beckman Coulter Inc.

Name: FDA recall Z-0309-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-06

Class III · Terminated

Class III FDA medical device recall by Beckman Coulter Inc., initiated 2017-11-06, terminated 2019-11-04. It names one FDA 510(k) clearance: K922823. Product: Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.. Reason: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment..

Recalling firm: Beckman Coulter Inc.
Classification: Class III
Status: Terminated
Initiated: 2017-11-06
Terminated: 2019-11-04
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K922823 — ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTSBio-Rad Laboratories, Inc.·cleared 1992-08-05

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

Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Reason for recall

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

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