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.
Recall
- Recall Number
- Z-1401-2013
- Event Number
- 65048
- Firm
- Alere San Diego, Inc.
- FEI Number
- 1000125596
- Product Code
- JHI
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- April 16, 2013
- Posted
- May 25, 2013
- Terminated
- October 18, 2013
- Address
- 9975 Summers Ridge Rd, San Diego, CA, 92121-2997
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.
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
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.
United States Nationwide Distribution
3975 kits