Z-0222-2007

NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use

Name: Z-0222-2007 NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Creator: Inverness Medical Professional Diagnostics
Published: 2006-09-29
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2006-09-29 / Terminated / root cause: labeling and UDI

FDA source

Inverness Medical Professional Diagnostics began a recall of NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000 on 2006-09-29. The reason FDA records is "Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0222-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2006-11-29
Terminated: 2007-03-13
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
Product code: MJH Legionella, Spp., Elisa
Reason for recall: Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level.
Quantity in commerce: 531 kits
Distribution: Worldwide, including USA, Canada, EU, South Korea, Singapore
Product codes and lots: Lot Number: 024448 Exp. Date: March 14, 2008

Product code MJH

K982238Class IIBinax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522Binax, Inc. / cleared 1998-08-21

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)