BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits
BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.
What this means for you
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 recall is classified as FDA Class II, and the hazard involves a risk of harm (false negatives in diagnostic testing) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BioMerieux SA is recalling 2,160 units of the VIDAS D-Dimer Exclusion II automated quantitative test. This medical device is used to determine fibrin degradation products in human plasma and is indicated for use in conjunction with clinical pretest probability assessment models to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease.
The recall was initiated due to customer complaints regarding non-repeatable results below the detection limit of 45 ng/mL. These issues have led to reported false negatives for results around the medical decision point of 500 ng/mL, where initial tests indicated values below 45 ng/mL.
The affected lots are 1001625210, 1001715580, 1001711530, 1001789540, and 1001932680. The products were distributed to facilities in 38 states, including Alabama, Arkansas, California, and Texas. Healthcare providers and laboratories should stop using the affected units and contact BioMerieux SA for further instructions.
The recalled product
- Product
- VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction w
- Manufacturer
- BioMerieux SA
- Affected units
- 2,160
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 (10)
- Reference 304551-01 - Lots 1001625210
- Exp. date 8/8/20123
- 1001715580
- Exp. date 9/26/2013
- 1001711530
- Exp. date 9/11/2013
- 1001789540
- Exp. date 10/29/2013
- 1001932680
- Exp. date 12/12/2013
Distribution
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