Focus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs
Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or 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 Inc is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa Group A Strep Direct kits (MOL2850). The recall also covers DADs supplied with the Simplexa HSV 1 & 2 Direct (MOL2150) and Simplexa Flu A/B & RSV Direct (MOL2650) kits. The affected units are identified by specific item numbers and lot/serial numbers listed in the official recall notice.
The recall was initiated because the discs may result in a false negative result, a false positive result, or Error codes 500 or 505. Additionally, the discs may result in higher invalid rates. These issues could lead to incorrect diagnostic conclusions for patients.
The affected products were distributed worldwide, including nationwide in the United States and in various international countries. Consumers and healthcare providers should stop using the affected discs and contact Focus Diagnostics for instructions on how to return or replace the product.
The recalled product
- Product
- Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 41
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.
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