CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Microalbumin Calibrator Series recalled by Randox Laboratories
Randox Laboratories is recalling Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay, distributed nationwide in the US. The recall was initiated on 31 Jan 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-1593-2024
- FDA event ID
- 94138
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jan 2024
- FDA classified
- 17 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 31 Jan 2024 | Recall initiated by company | |
| 17 Apr 2024 | Classified by FDA | +77 days |
| 24 Apr 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
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
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
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Where it was distributed
US Nationwide distribution in the states of GA, MA, WV including PR.
Questions about this recall
Why was it recalled?
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Which lots are affected?
GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Where was it sold?
US Nationwide distribution in the states of GA, MA, WV including 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 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.
Other products in this recall event
1 other product · FDA event 94138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Microalbumin Calibrator Series recalled by Randox Laboratories | Randox Laboratories | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
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