Z-2881-2011

Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the...

Name: Z-2881-2011 Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the...
Creator: Alere San Diego
Published: 2011-06-10
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2011-06-10 / Terminated / root cause: supplier

FDA source

Alere San Diego began a recall of Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug... on 2011-06-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2881-2011
Status: Terminated
Initiated: 2011-06-10
Posted: 2011-07-27
Terminated: 2012-04-04
Recalling firm: Alere San Diego, Inc.
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.
Product code: DKZ Enzyme Immunoassay, Amphetamine
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.
Root cause tag: supplier
FDA 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 [email protected].
Quantity in commerce: 2400 kits (60,000 devices)
Distribution: (USA) Nationwide Distribution including the states of MO and MA.
Product codes and lots: Model/Catalog Number: DOA-197-201-19-0NW506A, Lot/Unit Codes: DOA1040725, DOA1040758, DOA1040784, DOA1040669 & DOA1040689

Product code DKZ

K061718Class IIInnovacon Spectrum II Test CardInnovacon, Inc. / cleared 2006-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)