Abbott m2000sp, an automated system for performing sample… recallZ-0463-2015 · Abbott Molecular · initiated Oct 23, 2014
Class II Terminated All recalls posted in November 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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: Software error) to be generated when the Available Reagent Packs screen is selected.
FDA root cause category: Software design (manufacturing process)
What the company is doing
Field Correction Recall / Urgent Field Safety Notice letters dated September 23, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) review the app spec files that are installed on the m2000sp system and delete any incompatible app specs; 2) if one or more app spec files were deleted, installation of new app spec file(s) is needed; and, 3) review this information with laboratory personnel and retain the letter for future reference. Customers with questions about this market action can contact Technical Support at 800-553-7042, Option 2, or the local Abbott Molecular representative.
Recall details
- Recall number
- Z-0463-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 23, 2014
- Posted by the FDA
- Nov 25, 2014
- Recalling firm
- Abbott Molecular
- Quantity
- 9 CD ROMs (US); 1,273 CD ROMs (Foreign)
- Product code
- JJH
- FDA submissions
- K092705
- Distribution
- 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
Product description
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Code information (models, lots, serial numbers)
List Number: 09K14; Models: E series, G series
Other devices under the same FDA submission
2 devices cleared under K092705 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- m2000 09K14-02Abbott Molecular Inc. · CLINICAL SAMPLE CONCENTRATOR23 reports
- m2000 9K15-01Abbott Molecular Inc. · real time Nucleic acid amplification system6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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