SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) SR10352Recalls & reported problems
Randox Laboratories Limited · Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 1, 2022Class IITerminated
***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
Z-1772-2022 · Root cause: Process change control · Recall details · FDA record ↗
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- VIDAS® Quality Control 30706Biomerieux SA · Multi-analyte controls unassayed2 recalls0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0044NMicrobiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- QC Sets and Panels: KWIK-STIK™ 8164Microbiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- Multichem ID-B SR103BTechno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed2 recalls0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0041NMicrobiologics Inc. · Multi-analyte controls unassayed1 recall0 reports
- Multichem S Plus 08P88-10Techno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed1 recall0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0071NMicrobiologics Inc. · Multi-Analyte Controls Unassayed1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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