5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime Sy
FDA device recall Z-2169-2014 · posted 2014-08-08 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- Reason for recall
- Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
- Action taken
- Abbott sent a Field Correction Recall / Urgent Field Safety Notice dated July 3, 2014, to all affected customers. June 19, 2014 were sent to all customers. The letters instructed customers to: 1) examine their inventories, 2) remove any of the affected lots, and 3) contact their Abbott Molecular Representativeat 1-800-553-7042 to coordinate replacement. Customers were also instructed to review this information with laboratory personnel and retain the communication for future reference. For questions regarding this recall call 224-361-7274
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JJH
- Quantity affected
- 1,688,000 reaction vessels
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to: AUSTRALIA AUSTRIA BELGIUM BENIN CAMEROON CHINA ETHIOPIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND ISRAEL ITALY KENYA MALAYSIA MAL
- Date initiated
- 2014-06-19
- Date posted
- 2014-08-08
- Date terminated
- 2016-02-23
- Location
- Des Plaines, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |