Recall Z-1401-2013— Alere San Diego, Inc.

Name: FDA recall Z-1401-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-16

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2013-04-16, terminated 2013-10-18. It names one FDA 510(k) clearance: K062361. 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.. Reason: 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.

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-16
Terminated: 2013-10-18
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062361 — INNOVACON HCG UKTRA TEST DEVICEInnovacon, Inc.·cleared 2006-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.