Microgenics Recalls DRI Cocaine Metabolite Assay Due to Reagent Degradation
Microgenics Corp is recalling specific lots of DRI Cocaine Metabolite Assay because surveillance showed unexpected reagent degradation. The recall affects 1,473 units distributed across multiple US states.
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, but the source text does not report any illnesses or injuries, and the hazard is related to reagent stability rather than a direct physical injury risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Microgenics Corp is recalling specific lots of the DRI Cocaine Metabolite Assay, which is labeled as the Multigent Cocaine Assay for Abbott Laboratories. The product is an in vitro diagnostic (IVD) reagent intended for the qualitative and semi-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine. The recall was initiated after surveillance of reagent stability for specific lots showed an unexpected decreasing change in the reaction rate, indicating faster than expected reagent degradation.
The recall involves 1,473 units in distribution. The affected lots include Part No. 0055 (Lot 60053405), Part No. 0056 (Lot 60053396), and Part No. 10014593 (Lot 60112588), all with an expiration date of 2/29/2016. Additionally, Part number #l40-20 (Lot 24215M500, Exp 8/13/14) is listed as not distributed. The products were distributed in the US, including the states of DC, MA, NJ, TX, FL, CA, WA, NY, CT, KY, LA, AR, TN, AL, GA, VA, NC, KS, MD, OH, and IL.
This is an FDA Class II recall. The source text does not report any illnesses or injuries associated with the use of these specific lots. Healthcare facilities and laboratories should stop using the affected lots and contact Microgenics Corp for further instructions.
The recalled product
- Product
- DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the…
- Manufacturer
- Microgenics Corp
- Hazard
- Affected units
- 1,473
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)
- Part no. 0055
- lot number 60053405
- Exp 2/29/2016
- Part No. 0056
- lot number 60053396
- Part No. 10014593
- lot number 60112588
- - not distributed Part number #l40-20
- lot number 24215M500
- Exp 8/13/14.
Distribution
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