Recall Z-1401-2013 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Alere San Diego, Inc.
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.
| Date | May 25, 2013 (initiated Apr 16, 2013) |
| Status | Terminated |
| 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 |
| 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 lateral.flow.support@alere.com.". A verification form was attached to the notification letter. |
| Quantity | 3975 kits |
| Distribution | United States Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062361 | INNOVACON HCG UKTRA TEST DEVICE Innovacon, Inc., Oct 23, 2006 |