Z-1764-2008

HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence...

Name: Z-1764-2008 HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence...
Creator: Focus Diagnostics Inc
Published: 2007-07-06
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2007-07-06 / Terminated / root cause: manufacturing process

FDA source

Focus Diagnostics Inc began a recall of HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2... on 2007-07-06. The reason FDA records is "A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1764-2008
Status: Terminated
Initiated: 2007-07-06
Posted: 2008-08-17
Terminated: 2009-06-25
Recalling firm: DiaSorin Molecular LLC
Product: HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.
Product code: LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Reason for recall: A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.
Quantity in commerce: Lot Code 063169 - 97 Kits, Lot Code 063354 - 16 Kits, Lot Code 063355 - 74 Kits
Distribution: Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
Product codes and lots: Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)

Product code LGC

K000238Class IIHsv-1 & Hsv-2 Differentiation Immunoblot Igg, Model Ib0900gMrl Diagnostics / cleared 2000-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)