Abbott m2000sp Instrument recallZ-0365-2012 · Abbott Molecular · initiated Oct 11, 2011
Terminated All recalls posted in January 2012
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
Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
FDA root cause category: Component design/selection
What the company is doing
Abbott Molecular sent a Field Correction Recall letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until further notice, and to complete the enclosed reply sheet and fax it to (847) 775-6728 at their earliest convenience to acknowledge receipt and understanding of the letter. For questions regarding this recall call 224-361-7133.
Recall details
- Recall number
- Z-0365-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 11, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Abbott Molecular
- Quantity
- 432 units
- Product code
- JJH
- FDA submissions
- K092705
- Distribution
- Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Australia, Austria, Azerbaijan, Belgium, Brazil, Burundi, Cameroon, China, Croatia, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Germany, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Libya, Malawi, Malaysia, Mali, Mozambique, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Vietnam and Zambia
Product description
Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
Code information (models, lots, serial numbers)
list 09K14, all serial numbers
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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