Device product
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI 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. Catalog Number: SR10349
Z-0624-2024
Product summary
- Event
- Event 93543
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0624-2024
Official wording
Reason: 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.
Code information: GTIN: 05055273216424 Bath/Lot Number: 157SR
Distribution pattern: NY, WV
Derived failure modes
-
Unknown
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.