CLASS III Device recall · Reported 17 Apr 2019 · FDA Enforcement Report
Immunoassay Premium Plus Controls recalled by Randox Laboratories
Randox Laboratories is recalling Immunoassay Premium Plus Controls, distributed in Puerto Rico, West Virginia. The recall was initiated on 7 Feb 2019 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-1106-2019
- FDA event ID
- 82184
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Feb 2019
- FDA classified
- 8 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 7 Feb 2019 | Recall initiated by company | |
| 8 Apr 2019 | Classified by FDA | +60 days |
| 17 Apr 2019 | 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 target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
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, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Where it was distributed
The products were distributed to the following US states: WV and Puerto Rico.
Stores named: Target
Questions about this recall
Is Immunoassay Premium Plus Controls recalled?
Yes. Randox Laboratories recalled Immunoassay Premium Plus Controls on 7 Feb 2019. The recall is Class III and its status is Terminated. Recall number Z-1106-2019.
Why was it recalled?
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Which lots are affected?
Lot codes: 1714EC 430312 432364
Where was it sold?
The products were distributed to the following US states: WV and Puerto Rico.
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 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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