Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1401-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 16, 2013

Date Posted: June 5, 2013

Recall Number: Z-1401-2013

Event ID: 65048

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

Status: Terminated

Product Quantity: 3975 kits

Code Information:

Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13

Distribution Pattern:

United States Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated