Z-2169-2014 Class II Terminated
FDA device recall Z-2169-2014 was initiated by Abbott Molecular on Jun 19, 2014 and is designated Class II. 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… The recall status is terminated (terminated Feb 23, 2016). Affected quantity: 1,688,000 reaction vessels.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- Jun 19, 2014
- Termination Date
- Feb 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,688,000 reaction vessels
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to: AUSTRALIA AUSTRIA BELGIUM BENIN CAMEROON CHINA ETHIOPIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND ISRAEL ITALY KENYA MALAYSIA MALAWI MALI NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PHILIPPINES POLAND PORTUGAL RUSSIA SENEGAL SINGAPORE SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE UNITED KINGDOM VIETNAM
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2169-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026