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Open, Classified

Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

FDA Recall Z-1328-2024 · Posted 2024-03-20

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJIX
Date Initiated2024-03-01
Product Quantity1,764 units

Reason for Recall

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

Firm Action

Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to [email protected] within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic: CA, FL, IL, ME, NJ, OH, & OR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061056RANDOX LIQUID PROTEIN CALIBRATORRandox Laboratories, Ltd. · 2006-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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