CLASS II Device recall · Reported 27 Feb 2019 · FDA Enforcement Report
Randox Calcium (Ca) Colorimetric Method RX Daytona Plus recalled
Randox Laboratories is recalling Randox Calcium (Ca) Colorimetric Method RX Daytona Plus, distributed in Puerto Rico, West Virginia. The recall was initiated on 4 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0840-2019
- FDA event ID
- 81746
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2018
- FDA classified
- 15 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Dec 2018 | Recall initiated by company | |
| 15 Feb 2019 | Classified by FDA | +73 days |
| 27 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Where it was distributed
WV, PR
Questions about this recall
Is Randox Calcium (Ca) Colorimetric Method RX Daytona Plus recalled?
Yes. Randox Laboratories recalled Randox Calcium (Ca) Colorimetric Method RX Daytona Plus on 4 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0840-2019.
Why was it recalled?
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Which lots are affected?
All lot codes
Where was it sold?
WV, PR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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