Z-0282-2020Class II

Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039

Name: Z-0282-2020 Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039
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 Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced... 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-0282-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-09
Posted: 2019-11-04
Terminated: 2021-01-08
Recalling firm: Randox Laboratories, Limited
Product: Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.
Product code: DHR System, Test, Rheumatoid Factor
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: 17 kits
Distribution: US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
Product codes and lots: Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2020
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 DHR

K972220Class IIRheumatoid Factor Latex-Enhanced Immunoturbidimetric Test KitRandox Laboratories, Ltd. / cleared 1997-09-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)