FDAClass IIIJanuary 10, 2024

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for recall

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM…

Why was SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: 05055273216424 Bath/Lot Number: 157SR

Product
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM…
Recalling firm
Randox Laboratories Ltd.
Quantity
1 unit
Distribution
NY, WV
Recall date
January 10, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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