Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect
Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical defect (insufficient rim) that could cause the vessel to drop, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Abbott Molecular is recalling 5 mL Reaction Vessels (RVs) that are consumables for the Abbott m2000sp Automated Fluid Handling System. The affected lots are 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077). The recall involves 1,688,000 reaction vessels distributed nationwide in the United States and internationally to numerous countries including Australia, China, Germany, India, and the United Kingdom.
The recall was initiated because some of the reaction vessels may have an insufficient rim. This defect may prevent the vessels from being held securely in the 1 mL Subsystem Carrier, potentially causing the vessels to be seated incorrectly or drop through the carrier. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories.
Clinical laboratories using the Abbott m2000 RealTime System should check their inventory for the affected lot numbers and stop using the recalled reaction vessels. Users should contact Abbott Molecular for further instructions on how to handle the affected product.
The recalled product
- 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
- Manufacturer
- Abbott Molecular
- Affected units
- 1,688,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Unique Product Identifier: 04J71-20
- Serial Numbers: 56944001
- 57026001
- 57059001
- 57673001
Distribution
Distributed nationwide across the United States.
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