Innominata Lyme Disease Microplate EIA Kit Recalled for Low-Reactivity Issues
Innominata dba GenBio is recalling 195 units of the Anti-Borrelia (Lyme) Microplate EIA Kit due to multiple incidents of low-reacting assay plates.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Innominata dba GenBio is recalling 195 units of the Anti-Borrelia (Lyme) Microplate EIA Kit, Catalog # 32507, Lot Number 120960. The product was manufactured for Bio-Rad and is used as an aid in the diagnosis of Lyme disease.
The recall was initiated due to multiple incidents of low-reacting assay plates. The affected units were distributed nationwide to California, Illinois, Massachusetts, Maryland, Maine, North Carolina, North Dakota, New Jersey, New York, Oregon, Virginia, and Wisconsin.
Consumers and healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in…
- Manufacturer
- Innominata Dba Genbio
- Hazard
- Affected units
- 195
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)
- Lot #120960 (121003. 121058
- 121002)
- Exp./Cad/Verw/bis: 2013-09
- Catalog#802-3011
- 25271
- 25272
- 25273
- Label P/N 522-0040
- 522-0037
- 522-0011
Distribution
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