FDA Device recall Z-1272-2016
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL14…
- FDA Device
- Class I
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class I recall of Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL14… by Focus Diagnostics, citing 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 Gro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1272-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-10 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Focus Diagnostics |
| Distribution | US |
Product
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Reason
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 false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Identifiers
| code_info | Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201…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, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620. 3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1272-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.