Z-0285-2018Class II

Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This...

Name: Z-0285-2018 Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This...
Creator: Randox Laboratories Ltd.
Published: 2017-06-07
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2017-06-07 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments... on 2017-06-07. FDA classified it as Class II and gives the reason as "Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product". 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-0285-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2017-12-22
Terminated: 2018-07-02
Recalling firm: Randox Laboratories, Limited
Product: Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox Laboratories sent an Urgent Field Safety Notice dated June 6, 2017, sent to all global consignees on June 7, 2017, via e-mail. This includes the sole US consignee. Customers are advised to dispose of any existing stock and to contact technical support with respect to reimbursement for loss of material. The company will follow up every 2 weeks over a six week period with the consignees. For further questions, please call (304) 728-2890.
Quantity in commerce: 90 kits
Distribution: Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
Product codes and lots: Lot/Batch 414553, expiry 28th Jan 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0285-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0285-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-22

Product code LCP

K021897Class IIRandox Haemoglobin A1cRandox Laboratories, Ltd. / cleared 2002-11-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)