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Alere San Diego Inc. Recalls

1 recall on record · June 20, 2018 to June 20, 2018 · Medical Devices

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The recall feeds record what looks like the same company under more than one name:

Alere San Diego (49)

June 20, 2018Medical DevicesFDA

Alere San Diego Inc. DBA Immunalysis Corporation recalls lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control ma

Hazard: The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.

Alere San Diego Inc. Recalls | RecallWatchUSA