Recall Z-2778-2016— Alere San Diego, Inc.

Name: FDA recall Z-2778-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-02

Class III · Terminated

Class III FDA medical device recall by Alere San Diego, Inc., initiated 2016-08-02, terminated 2016-10-28. It names one FDA 510(k) clearance: K120615. Product: LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.. Reason: Incorrect expiration date on the magnetic strip that does not match the labeled expiration date..

Recalling firm: Alere San Diego, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-08-02
Terminated: 2016-10-28
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120615 — ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTEAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen·cleared 2013-05-15

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

LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

Reason for recall

Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

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