CLASS II Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
The Randox Serology I Positive Control contains recalled
Randox Laboratories is recalling The Randox Serology I Positive Control contains the following analytes in human based, distributed nationwide in the US. The recall was initiated on 1 Aug 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-1772-2022
- FDA event ID
- 90777
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2022
- FDA classified
- 19 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Aug 2022 | Recall initiated by company | |
| 19 Sep 2022 | Classified by FDA | +49 days |
| 28 Sep 2022 | 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
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
Product as listed by the FDA
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
Where it was distributed
US Nationwide distribution in the states of WV, NC.
Questions about this recall
Is The Randox Serology I Positive Control contains the following analytes in human based recalled?
Yes. Randox Laboratories recalled The Randox Serology I Positive Control contains the following analytes in human based on 1 Aug 2022. The recall is Class II and its status is Terminated. Recall number Z-1772-2022.
Why was it recalled?
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
Which lots are affected?
GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
Where was it sold?
US Nationwide distribution in the states of WV, NC.
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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