Focus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors
Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.
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 3/5 (High).
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 involves a risk-of-harm product (medical diagnostic) where injury or illness has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Focus Diagnostics Inc. is recalling Simplexa Direct Amplification Discs (DAD) used with the Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct, and Simplexa Group A Strep Direct kits. The recall involves 7,421 units distributed worldwide, including in the United States and various international markets.
The recall was initiated because the discs may result in false negative results, false positive results, or specific error codes (500 or 505). Additionally, the affected discs may lead to higher invalid rates in diagnostic testing.
Consumers and healthcare providers should stop using the affected Direct Amplification Discs and contact Focus Diagnostics for further instructions or replacement.
The recalled product
- Product
- Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 7,421
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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