Z-0953-2009

LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO...

Name: Z-0953-2009 LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO...
Creator: Millipore Corporation
Published: 2008-11-24
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2008-11-24 / Terminated

FDA source

Millipore Corporation began a recall of LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK)... on 2008-11-24. The reason FDA records is "Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0953-2009
Status: Terminated
Initiated: 2008-11-24
Posted: 2009-03-06
Terminated: 2012-08-10
Recalling firm: EMD Millipore Corporation
Product: LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet
Product code: GNW Antisera, Cf, Influenza Virus A, B, C
Reason for recall: Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
FDA root cause: Pending
Action: Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail. Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.
Quantity in commerce: 404 units
Distribution: Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
Product codes and lots: Lot Numbers: JBC1531415, TR1480748, and TR1501924.

Product code GNW

K974302Class ILight Diagnostics Simulfluor Flu A/flu BLight Diagnostics / cleared 1998-04-08

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)