Z-2169-2014Class II

5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000...

Name: Z-2169-2014 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000...
Creator: Abbott Molecular
Published: 2014-06-19
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2014-06-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Molecular began a recall of 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... on 2014-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2169-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-19
Posted: 2014-08-08
Terminated: 2016-02-23
Recalling firm: Abbott Molecular, Inc.
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.
Product code: JJH Clinical Sample Concentrator
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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
Quantity in commerce: 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 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
Product codes and lots: Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2169-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2169-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-08

Product code JJH

K092705Class IIAbbott M2000sp and Abbott M2000rt, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Abbott Molecular, Inc. / cleared 2010-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)