FDA Medical Device Recalls (openFDA)
Alere San Diego: Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
- Recall number
- Z-2881-2011
- Recalling firm
- Alere San Diego
- Product
- Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
- Status
- Terminated
- Initiated
- 2011-06-10
- Posted
- 2011-07-27
- Terminated
- 2012-04-04
- Reason
- 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.
- Root cause
- Vendor change control
- Action
- 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.
- Quantity
- 2400 kits (60,000 devices)
- Distribution
- (USA) Nationwide Distribution including the states of MO and MA.
- Lot, serial or model codes
- Model/Catalog Number: DOA-197-201-19-0NW506A, Lot/Unit Codes: DOA1040725, DOA1040758, DOA1040784, DOA1040669 & DOA1040689
- 510(k) numbers
- ["K061718"]
- PMA numbers
- not on file
- Product code
- DKZ
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28