Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Recall Z-0904-2023 · Posted 2023-01-05
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Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJJY
Date Initiated2022-11-22
Product Quantity115 units
Reason for Recall
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
Firm Action
Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22.
The Urgent Medical Device Correction letter states reason for recall, health risk and action to take:
Discard previous IFUs and download the updated IFUs from randox.com
Review results generated with the affected batches in line with the clinical profile of
the patient.
Discuss the contents of this notice with your Medical Director.
Complete and return the response form 12187-QA to [email protected]
within five working days.
Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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