The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1272-2016·Announced 2016-04-13

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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) because it may result in a…"

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
Category
Medical Device — Diagnostic Test Kit
Hazard
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

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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 →

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