Recall Z-1306-2023— Instrumentation Laboratory

Name: FDA recall Z-1306-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-03

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2023-02-03. It names one FDA 510(k) clearance: K090209. Product: ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R. Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments.

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2023-02-03
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory CO·cleared 2009-06-02

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

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

Reason for recall

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

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