5 mL Reaction Vessels (a consumable of the Abbott m2000sp… recallZ-2169-2014 · Abbott Molecular · initiated Jun 19, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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
Recall details
- Recall number
- Z-2169-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 19, 2014
- Posted by the FDA
- Aug 8, 2014
- Recalling firm
- Abbott Molecular
- Quantity
- 1,688,000 reaction vessels
- Product code
- JJH
- FDA submissions
- K092705
- 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 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.
Code information (models, lots, serial numbers)
Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001
Other devices under the same FDA submission
2 devices cleared under K092705 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- m2000 09K14-02Abbott Molecular Inc. · CLINICAL SAMPLE CONCENTRATOR23 reports
- m2000 9K15-01Abbott Molecular Inc. · real time Nucleic acid amplification system6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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