Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results
Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.
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: The product is a Class II medical device that produces inaccurate diagnostic test results, creating a risk-of-harm situation. No illnesses or injuries have been reported, which limits the score to 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards (Lot Number PPD02102 V6) due to inaccurate blood glucose test results. The recall affects 179,750 cards with catalog number CMT01 and GTIN 1061C010890976 that were distributed nationwide in Maryland and North Carolina.
The blood collection cards produce inaccurate—specifically, elevated—blood glucose test results. This affects the accuracy of diagnostic test results obtained from this product lot.
Customers with questions or concerns should contact Advance Dx, Inc. for additional information.
The recalled product
- Product
- Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
- Manufacturer
- Advance Dx, Inc.
- Affected units
- 179,750
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)
- Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6
Distribution
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