Sight OLO CBC Test Kit Lot Recalled for Bacterial Contamination
One lot of Sight OLO CBC Test Kit is being recalled due to bacterial contamination that causes artificially elevated platelet counts. The affected kits may produce inaccurate test results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves bacterial contamination in a medical device without reported illnesses or injuries. Per the rubric, high-risk pathogens without reported illness constitute a score of 3. The contamination causes diagnostic inaccuracy, representing significant risk to patient care through unreliable test results.
Plain-English summary
One lot of the Sight OLO CBC Test Kit (Model TK1-10114) is being recalled due to bacterial contamination found in the test cartridges. The contamination causes the kit to report artificially elevated platelet counts with a bias of 7.5 k/ul, meaning results are higher than they should be. This performance falls outside the device's specified accuracy standards.
The affected lot was distributed worldwide across 7,450 total units. In the United States, 2,800 units were distributed to Alabama, Florida, Mississippi, Texas, and Wisconsin. An additional 4,650 units were distributed internationally to Canada, Israel, Slovenia, and Trinidad & Tobago.
Healthcare providers and facilities using this test kit lot should discontinue use immediately. Patients whose test results were based on this affected lot may need retesting with an unaffected kit to ensure accurate platelet counts. Contact SIGHT DIAGNOSTICS LTD for guidance on returning the affected test kits and obtaining replacements.
The recalled product
- Product
- Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
- Manufacturer
- SIGHT DIAGNOSTICS LTD
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 (3)
- REF: TK1
- UDI-DI: B787TK10
- Lot Code: 10114
Distribution
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