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.
Reported: September 21, 2016 Initiated: August 2, 2016 #Z-2778-2016
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.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 12,951
- Distribution
- Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alere San Diego, Inc.. Units affected: 12,951.
Why was this product recalled? ▼
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Low. Recall number: Z-2778-2016.
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