Recall Z-2670-2011 ยท DKZ Enzyme Immunoassay, Amphetamine
Ameditech Inc
SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a prelim
| Date | Jun 27, 2011 (initiated Apr 26, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance. |
| Root cause | Process control |
| Action | Ameditech, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter requested the customer to: (1) Cease distribution of the affected lot and provide remaining inventory count to Ameditech. (2) Destroy any remaining inventory of these lots and document destruction per your site requirements. (3) Ensure that all users of the device receive a copy of the Urgent Medical Device Recall letter. A recall verification form was attached to the letter to be completed |
| Quantity | 6000 test cards (120 kits) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |