Z-1401-2013Class II

Alere" hCG Combo Cassette (20/10 mIU/mL) Kit

Name: Z-1401-2013 Alere" hCG Combo Cassette (20/10 mIU/mL) Kit
Creator: Alere San Diego, Inc.
Published: 2013-04-16
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-04-16 / Terminated / root cause: packaging

FDA source

Alere San Diego, Inc. began a recall of Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the... on 2013-04-16. FDA classified it as Class II and gives the reason as "The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1401-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-16
Posted: 2013-05-25
Terminated: 2013-10-18
Recalling firm: Alere San Diego, Inc.
Product: Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for
Root cause tag: packaging
FDA root cause: Packaging
Action: Alere initiated this recall by sending recall notification letters, titled "URGENT MEDICAL DEVICE RECALL", dated April 16, 2013 via via fax, email or direct mail. The letter informed customers of the product recalled, reason for recall, customer required action, and contact information, "Alere Technical Services at 866-216-0094 or by e-mail at [email protected].". A verification form was attached to the notification letter.
Quantity in commerce: 3975 kits
Distribution: United States Nationwide Distribution
Product codes and lots: Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1401-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1401-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code JHI

K062361Class IIInnovacon Hcg Uktra Test DeviceInnovacon, Inc. / cleared 2006-10-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)