Abbott Molecular: Medical Device Recall in 2014 - (Recall #: Z-2169-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 19, 2014

Date Posted: August 20, 2014

Recall Number: Z-2169-2014

Event ID: 68617

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.

Status: Terminated

Product Quantity: 1,688,000 reaction vessels

Code Information:

Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001

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

Voluntary or Mandated:

Voluntary: Firm initiated