Z-0463-2015 Class II Terminated
FDA device recall Z-0463-2015 was initiated by Abbott Molecular on Oct 23, 2014 and is designated Class II. Reason for recall: Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred… The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 9 CD ROMs (US); 1,273 CD ROMs (Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 3, 2014
- Initiation Date
- Oct 23, 2014
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 CD ROMs (US); 1,273 CD ROMs (Foreign)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0463-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026