Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure
Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard is a performance failure that may affect test accuracy without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK, Reference R01626, Lot 307200. The product is a medical device used in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins.
The recall was initiated because the product may fail performance testing for S aureus ATCC 43300. This failure could affect the accuracy of the screening procedures for which the product is intended.
The affected units were distributed nationwide in the United States. Users of this product should stop using the recalled units and contact Thermo Fisher for further instructions or a replacement.
The recalled product
- Product
- remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin…
- Manufacturer
- Thermo Fisher
- Hazard
- Affected units
- 67
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 (1)
- Lot: 307200
Distribution
Distributed nationwide across the United States.
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