Reported Sep 21, 2016 · Terminated
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is…
Alere San Diego, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- LDX Optical
- Check Cassettes (OCC) Model Number10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer
- Product UsageThe 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
- Lot codes and dates
- Model Number10-228
- and 14-535 Lot Number332994
- Amount recalled
- 12,951
Where it was sold
Why it was recalled
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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