FDA Device recall Z-2169-2014
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System)
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System) by Abbott Molecular, citing 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 ins….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2169-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-19 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
Reason
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.
Identifiers
| code_info | Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2169-2014%22
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