Product Recalls & Refunds Online / National

Randox Laboratories Ltd.: Randox Liquid Urine Control Level 2- intended for in

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.. Recalled by Randox Laboratories Ltd.. Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.. Classification (Class II — potential health risk). Affected lots/dates:

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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