Z-0660-2019Class II

SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox...

Name: Z-0660-2019 SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox...
Creator: Randox Laboratories Ltd.
Published: 2018-11-19
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-11-19 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM... on 2018-11-19. FDA classified it as Class II and gives the reason as "Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected". 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-0660-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-19
Posted: 2018-12-21
Terminated: 2020-04-23
Recalling firm: Randox Laboratories, Limited
Product: SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product. - Return the completed response form via email to [email protected]. If you have any questions, contact RA Specialist by email at [email protected].
Quantity in commerce: 250 kits (32 kits US / 218 kits OUS)
Distribution: US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
Product codes and lots: 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0660-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0660-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-21

Product code JIX

K031608Class IIRandox Liquid Protein CalibratorRandox Laboratories, Ltd. / cleared 2003-08-08

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)