SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) SR10349Recalls & reported problems
Randox Laboratories Limited · ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgM 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Nov 6, 2023Class IIIOpen, Classified
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Z-0624-2024 · Root cause: Process control · Recall details · FDA record ↗
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- 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
- SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) SR10352Randox Laboratories Limited · Multi-Analyte Controls Unassayed1 recall0 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
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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