Z-1144-2014Class II

Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of...

Name: Z-1144-2014 Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of...
Creator: Focus Diagnostics Inc
Published: 2014-02-04
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2014-02-04 / Terminated

FDA source

Focus Diagnostics Inc began a recall of Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in... on 2014-02-04. FDA classified it as Class II and gives the reason as "Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1144-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-04
Posted: 2014-03-05
Terminated: 2014-11-01
Recalling firm: DiaSorin Molecular LLC
Product: Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Product code: OOC
Reason for recall: Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.
FDA root cause: Under Investigation by firm
Action: Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.
Quantity in commerce: 2,175 kits
Distribution: Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Product codes and lots: Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1144-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1144-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-05

Product code OOC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)