Focus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs
Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.
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: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, aligning with a Moderate severity score for a diagnostic error risk without reported injuries.
Plain-English summary
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650), and Simplexa Group A Strep Direct kits (MOL2850). The recall involves 1,845 units of the product.
The recall is being conducted because the discs may result in a false negative result, a false positive result, or Error code(s) 500 or 505. Additionally, the discs may result in higher invalid rates.
The affected products were distributed worldwide, including in the United States and various international countries. Consumers and healthcare providers should stop using the affected Direct Amplification Discs and contact Focus Diagnostics for further instructions.
The recalled product
- Product
- Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 1,845
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 (20)
- Item Number MOL1451
- Lot/Serial: 151870
- 152535
- 152359
- 152550
- 152551
- 152756
- 152770
- 160008
- 160009
- 160198
- 160201
- 160248
- 160262. Item Number MOL1455
- Lot/Serial: 29230
- 29232
- 29233
- 29453
- 29454
- 29669
Distribution
Part of a larger recall action
This product is one of 3 recalled by Focus Diagnostics 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.
See all 3 products in this recall →Related recalls
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