CLASS III Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
LDX Optical Check Cassettes (OCC) recalled by Alere San Diego
Alere San Diego is recalling LDX Optical Check Cassettes (OCC), distributed nationwide in the US. The recall was initiated on 2 Aug 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2778-2016
- FDA event ID
- 74940
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Aug 2016
- FDA classified
- 9 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Aug 2016 | Recall initiated by company | |
| 9 Sep 2016 | Classified by FDA | +38 days |
| 21 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew York
Questions about this recall
Why was it recalled?
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Which lots are affected?
Model Number: 10-228 and 14-535 Lot Number: 332994
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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