CLASS III Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) recalled
Randox Laboratories is recalling Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages), distributed nationwide in the US. The recall was initiated on 11 Aug 2017 and the FDA has classified it as Class III.
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-0970-2018
- FDA event ID
- 79076
- Recalling firm
- Randox Laboratories, Kearneysville, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Aug 2017
- FDA classified
- 12 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Aug 2017 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +213 days |
| 21 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
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
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Where it was distributed
Distribution US nationwide.
Questions about this recall
Why was it recalled?
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Which lots are affected?
Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)
Where was it sold?
Distribution US nationwide.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 79076This product is part of a recall event; the main page for the event is Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) recalled | Randox Laboratories | Potency & Assay | Nationwide |
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