Recall Z-0604-2024— Abbott Laboratories

Name: FDA recall Z-0604-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-19

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2023-10-19. It names 2 FDA 510(k) clearances: K061667, K051215. Product: Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.. Reason: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex)..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2023-10-19
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K061667 — CELL-DYN RUBY SYSTEMAbbott Laboratories·cleared 2006-07-10
K051215 — CELL-DYN SAPPHIRE SYSTEMAbbott Laboratories·cleared 2005-07-21

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

Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

Reason for recall

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

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