Z-1793-2014Class III

APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234

Name: Z-1793-2014 APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234
Creator: Gen-Probe Inc
Published: 2014-04-17
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2014-04-17 / Terminated / root cause: labeling and UDI

FDA source

Gen-Probe Inc began a recall of APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and... on 2014-04-17. FDA classified it as Class III and gives the reason as "Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner 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-1793-2014
Classification: Class III
Status: Terminated
Initiated: 2014-04-17
Posted: 2014-06-14
Terminated: 2014-08-26
Recalling firm: Hologic, Inc.
Product: APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
Product code: OIE Urine Collection Kit (Excludes Hiv Testing)
Reason for recall: Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots 2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter). For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support. Toll Free: 888-484-4747 Direct: 858-410-8511 Fax: 858-410-8250 Email: [email protected]
Quantity in commerce: 4,740 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).
Product codes and lots: Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1793-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1793-2014	Class III	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-13

Product code OIE

K003395Class IIGen-Probe Aptima Combo 2 AssayGen-Probe, Inc. / cleared 2001-05-21

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)