CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Randox Cholesterol- For the quantitative recalled by Randox Laboratories
Randox Laboratories is recalling Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum, distributed nationwide in the US. The recall was initiated on 22 Jun 2022 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-1424-2022
- FDA event ID
- 90522
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Jun 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +28 days |
| 27 Jul 2022 | 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
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Where it was distributed
Nationwide Distribution - MD, OR, PR, MT, WV
Questions about this recall
Is Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum recalled?
Yes. Randox Laboratories recalled Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum on 22 Jun 2022. The recall is Class II and its status is Terminated. Recall number Z-1424-2022.
Why was it recalled?
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Which lots are affected?
GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024
Where was it sold?
Nationwide Distribution - MD, OR, PR, MT, WV
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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