CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report
RX Series CYSC- Cystatin C Reagent -Intended recalled
Randox Laboratories is recalling RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox, distributed nationwide in the US. The recall was initiated on 7 Jun 2024 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-2425-2024
- FDA event ID
- 94858
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jun 2024
- FDA classified
- 24 Jul 2024
- Reported
- 31 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Jun 2024 | Recall initiated by company | |
| 24 Jul 2024 | Classified by FDA | +47 days |
| 31 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cystatin C Reagent marketed without a 510 (k)
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
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Where it was distributed
US Nationwide distribution in the states of AL, CA, GA, NY.
Questions about this recall
Why was it recalled?
Cystatin C Reagent marketed without a 510 (k)
Which lots are affected?
GTIN: 05055273208665 All lots
Where was it sold?
US Nationwide distribution in the states of AL, CA, GA, NY.
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 26 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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