FDA Medical Device Recalls (openFDA)
Ameditech Inc: ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
- Recall number
- Z-0526-2016
- Recalling firm
- Ameditech Inc
- Product
- ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
- Status
- Terminated
- Initiated
- 2015-11-16
- Posted
- not on file
- Terminated
- 2016-11-09
- Reason
- Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
- Root cause
- Nonconforming Material/Component
- Action
- A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.com.
- Quantity
- 7,805 kits
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307
- 510(k) numbers
- ["K052115","K113046","K113501"]
- PMA numbers
- not on file
- Product code
- JXM
- Firm FEI
- 3003789989
- 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