Z-0283-2020Class II

Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032

Name: Z-0283-2020 Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032
Creator: Randox Laboratories Ltd.
Published: 2019-08-09
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-08-09 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro... on 2019-08-09. FDA classified it as Class II and gives the reason as "The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0283-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-09
Posted: 2019-11-04
Terminated: 2021-01-08
Recalling firm: Randox Laboratories, Limited
Product: Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 1. Review your reagent inventory and replace the value sheet with the new values provided. 2. Review results generated with the affected batches in line with the clinical profile of the patient. 3. Discuss the contents of this notice with your Medical Director. 4. Complete and return the response form 12187-QA to [email protected] within five working days.
Quantity in commerce: 100 kits
Distribution: US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
Product codes and lots: Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0282-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0283-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-04

Product code JIX

K061056Class IIRandox Liquid Protein CalibratorRandox Laboratories, Ltd. / cleared 2006-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)