Reported Sep 11, 2019 · Terminated
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d -…
Alere San Diego, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes
- of 1837d and 1843d - Product UsageThe Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer
- Lot codes and dates
- Lot/Unit CodesLot
- codes of Meter Kits
418197418198418199418252& 418253
- Lot codes of Power Supplies
724599724604& 725914
- Serial Numbers
186 of 186 codes
AA184455AA184344AA184328AA184388AA184304AA184349AA184396AA184339AA184421AA184280AA184435AA184427AA184395AA183401AA184394AA184710AA184345AA184039AA184463AA184609AA184383AA184415AA184094AA184070AA184412AA183861AA184278AA184283AA184711AA184392AA184343AA184368AA184708AA184350AA184674AA184378AA184433AA184366AA184365AA184354AA184369AA184067AA184353AA184664AA184279AA184355AA184270AA184285AA184017AA184272AA184340AA184346AA184347AA184336AA184342AA184269AA184376AA184949AA184386AA184351
- Amount recalled
- 186 analyzer kits
Where it was sold
Why it was recalled
The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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