CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Cystatin C Calibrator - In vitro diagnostic (IVD) use recalled
Randox Laboratories is recalling Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox, distributed nationwide in the US. The recall was initiated on 14 Feb 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-1369-2024
- FDA event ID
- 94088
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Feb 2024
- FDA classified
- 22 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Feb 2024 | Recall initiated by company | |
| 22 Mar 2024 | Classified by FDA | +37 days |
| 3 Apr 2024 | 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
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
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
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Where it was distributed
US Nationwide distribution in the states of CA, IN.
Stores named: CVS
Questions about this recall
Why was it recalled?
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Which lots are affected?
GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Where was it sold?
US Nationwide distribution in the states of CA, IN.
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.
More recalls from Randox Laboratories
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|---|---|---|---|---|---|
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | RX Series CYSC- Cystatin C Reagent -Intended recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Clinical Chemistry Calibration Serum recalled by Randox Laboratories | Randox Laboratories | Other | Nationwide |
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