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Terminated

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.

FDA Recall Z-2169-2014 · Posted 2014-08-08

Recalling FirmAbbott Molecular
Recall StatusTerminated
Product CodeJJH
Date Initiated2014-06-19
Date Terminated2016-02-23
Product Quantity1,688,000 reaction vessels

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.

Firm Action

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

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501Abbott Molecular, Inc. · 2010-05-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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