FDAClass IIJanuary 11, 2023

Liquid Assayed Specific Protein Control Level 3- In recall

Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay…

Why was Liquid Assayed Specific Protein Control Level 3- In recalled?

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;

Product
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay…
Recalling firm
Randox Laboratories Ltd.
Quantity
49 units US
Distribution
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Recall date
January 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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