Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detectio
FDA device recall Z-2881-2011 · posted 2011-07-27 · Terminated
Recall details
- Recalling firm
- Alere San Diego
- Reason for recall
- Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.
- Action taken
- Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers. The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere. For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- DKZ
- Quantity affected
- 2400 kits (60,000 devices)
- Distribution
- (USA) Nationwide Distribution including the states of MO and MA.
- Date initiated
- 2011-06-10
- Date posted
- 2011-07-27
- Date terminated
- 2012-04-04
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVACON SPECTRUM II TEST CARD (K061718) | Innovacon, Inc. | 2006-11-13 |