Abbott in-vitro diagnostic kits shipped without U.S. approval or registration
Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.
What this means for you
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: This is a Class III medical device recall involving unapproved and unregistered products. No illnesses, injuries, or confirmed harm are reported in the source text. Per the rubric, Class III recalls are typically scored 1–2, and this regulatory compliance violation without reported harm warrants a Moderate severity score.
Plain-English summary
Abbott Molecular, Inc. is recalling two in-vitro diagnostic kits: the Abbott Vysis MDM2/CEP 12 FISH Probe Kit (REF 01N15-010) and the Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe (REF 01N34-020). These Fluorescence In Situ Hybridization (FISH) diagnostic kits are used in clinical laboratory testing.
The products were intended for export only and were not approved or registered in accordance with U.S. specifications. Despite this designation, they were shipped to U.S. customers without the required FDA approval or registration.
A total of 16 kits were distributed in Alabama, California, Illinois, Massachusetts, Maryland, Minnesota, New York, and Pennsylvania. Multiple lot numbers are affected, with specific lot information and expiration dates provided by the manufacturer.
Customers who have received these diagnostic kits should discontinue use and contact Abbott Molecular, Inc. for instructions on product return or replacement with properly approved alternatives.
The recalled product
- Product
- In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
- Manufacturer
- Abbott Molecular, Inc.
- Affected units
- 16
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 (12)
- (1) REF 01N15-010 - GTIN 00884999035362
- Lot #381146
- Exp. 2024-05-05
- #381870
- #382179 Exp. 2024-05-05
- #387021
- Exp. 2024-08-01
- #528081
- exp. 2023-11-16
- (2) REF 01N34-020 - GTIN 00884999000766
- Lot #522756
- Exp. 2023-06-21.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Molecular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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