Z-2095-2015Class II

Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay...

Name: Z-2095-2015 Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay...
Creator: Alere Scarborough, Inc. dba Binax, Inc.
Published: 2015-06-26
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2015-06-26 / Terminated

FDA source

Alere Scarborough, Inc. dba Binax, Inc. began a recall of Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid... on 2015-06-26. FDA classified it as Class II and gives the reason as "Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2095-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-26
Posted: 2015-07-16
Terminated: 2015-09-15
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
FDA root cause: Process change control
Action: Alere sent a Urgent Medical Device Recall letter dated June 26, 2015, to all affected consignees. Customers were instructed to cease use and discard any unused pouched Sample Receivers and Transfer Cartridges contained in Alere" i Influenza A & B PN 425-024, Lot 0073853. Pouched Sample Receivers and Transfer Cartridges are identified in the kit as part number 425-431 lot number 074005 or 074108. Replacement Sample Receivers and Transfer Cartridges will be provided to the customer. Customers with questions were instructed to call Alere Technical Services at 855-731-2288 or email [email protected].
Quantity in commerce: 257 Kits
Distribution: Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
Product codes and lots: Lot Number 0073853 (US distribution only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2095-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-16

Product code OCC

K141520Class IIAlere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. / cleared 2014-06-13

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)