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Terminated

Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

FDA Recall Z-1563-2021 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJIX
Date Initiated2021-03-29
Date Terminated2021-11-22
Product Quantity98 kits

Reason for Recall

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

Firm Action

On 03/29/2021, Randox issued an Urgent Medical Device Correction notice to customer via letter notifying them, Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator Calibration Serum Level 3. Action to be taken: -Discuss the contents of this notice with your Medical Director. -Complete and return the response form 12187-QA to technical.services@ randox.com within five working days. For questions or concerns contact Randox Technical Services.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, The Netherlands, Turkey, UK, Ukraine, USA, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053153RANDOX CALIBRATION SERUMRandox Laboratories, Ltd. · 2006-01-13

Official Source

View FDA Recall →

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

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