CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Liquid Assayed Chemistry Control Premium Plus Level recalled
Randox Laboratories is recalling Liquid Assayed Chemistry Control Premium Plus Level 3, distributed in Georgia, Ohio, Oregon, Pennsylvania, Texas, Virginia. The recall was initiated on 3 Aug 2023 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-2609-2023
- FDA event ID
- 92912
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2023
- FDA classified
- 19 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Aug 2023 | Recall initiated by company | |
| 19 Sep 2023 | Classified by FDA | +47 days |
| 27 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
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
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Where it was distributed
US States: GA, OH, OR, PA, TX, VA
GeorgiaOhioOregonPennsylvaniaTexasVirginia
Stores named: Target
Questions about this recall
Why was it recalled?
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Which lots are affected?
UDI-DI: 05055273208986; Lot Number: 1308UE
Where was it sold?
US States: GA, OH, OR, PA, TX, VA
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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