Remel Inc. Recalls Thermo Scientific VersaTREK REDOX 1 In Vitro Diagnostic Product
Remel Inc. is recalling specific lots of Thermo Scientific VersaTREK REDOX 1 in vitro diagnostic products because they failed to provide positive signals for Streptococcus pneumoniae.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a diagnostic failure (false negative) rather than a direct physical injury or contamination, fitting the Moderate severity criteria for a voluntary precautionary recall of a medical device.
Plain-English summary
Remel Inc. is voluntarily recalling 76 boxes of 50 bottles each of Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), IVD. The recall affects Segments 1, 5, and 6 only of Lot 492571, with an expiration date of 2015-10. The product is labeled with the firm name Remel Inc., Lenexa, KS.
The recall was initiated because the bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. This indicates a potential failure in the diagnostic performance of the product for that specific organism.
Distribution was made to Colorado, Illinois, Indiana, Nebraska, New Jersey, Pennsylvania, South Dakota, and a government facility located in Virginia. Users of the product should stop using the affected lots and contact Remel Inc. for further instructions or a replacement.
The recalled product
- Product
- Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
- Manufacturer
- Remel Inc
- Hazard
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 (4)
- Segments 1
- 5
- and 6 only of Lot 492571
- Exp. 2015-10
Distribution
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