Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecu
FDA device recall Z-0365-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- Reason for recall
- Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JJH
- Quantity affected
- 432 units
- Distribution
- Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Australia, Austria, Azerbaijan, Belgium, Brazil, Burundi, Cameroon, China, Croatia, Estonia, Ethiopia, Finland, France, G
- Date initiated
- 2011-10-11
- Date posted
- 2012-01-11
- Date terminated
- 2016-02-23
- Location
- Des Plaines, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705) | Abbott Molecular, Inc. | 2010-05-28 |