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.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- April 16, 2013
- Posted
- May 25, 2013
- Terminated
- October 18, 2013
- Recall Number
- Z-1401-2013
- Quantity
- 3975 kits
- Firm Location
- San Diego, CA
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
Distribution
United States Nationwide Distribution
Lot / Code Info
Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
Root Cause
Packaging
Action Taken
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 lateral.flow.support@alere.com.". A verification form was attached to the notification letter.