Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chroma
FDA device recall Z-1401-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- 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
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 3975 kits
- Distribution
- United States Nationwide Distribution
- Date initiated
- 2013-04-16
- Date posted
- 2013-05-25
- Date terminated
- 2013-10-18
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVACON HCG UKTRA TEST DEVICE (K062361) | Innovacon, Inc. | 2006-10-23 |