Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 3, 2018
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 Rea
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throug…
Randox Laboratories Ltd. recalled Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORI… - a moderate-severity action.
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORI… was recalled by Randox Laboratories Ltd. in January 3, 2018. Reason: Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent ma…. Check the official notice for the remedy. Verify recall #Z-0285-2018 with the FDA Devices before acting.
The recall
Randox Laboratories Ltd. issued this moderate-severity FDA Devices recall-Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent ma….
- Moderate
- severity level
- Class II
- classification
- January 3, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0285-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0285-2018) was formally reported on January 3, 2018, with the manufacturer initiating the action on June 7, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Randox Laboratories Ltd. is listed as the recalling firm, operating out of Crumlin (North), N/A. Federal records list the affected scope as 90 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
90 kits
Related Recalls
6
6 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0285-2018 |
| Date reported | January 3, 2018 |
| Date initiated | June 7, 2017 |
| Recalling firm | Randox Laboratories Ltd. |
| Firm location | Crumlin (North), N/A |
| Affected scope | 90 kits |
| Distribution | Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0285-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Randox Laboratories Ltd.. Units affected: 90 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2018. Severity: Moderate. Recall number: Z-0285-2018.
Where was the recalled product distributed? ▼
Distribution: Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0285-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 3, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.