Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Reported: October 21, 2015 Initiated: August 27, 2015 #Z-0122-2016
Product Description
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Reason for Recall
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 190 kits
- Distribution
- Nationwide Distribution.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.. Recalled by Alere San Diego, Inc.. Units affected: 190 kits.
Why was this product recalled? ▼
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2015. Severity: Low. Recall number: Z-0122-2016.
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