VERIGENE Processor SP — Class II medical device recall Z-1488-2021
Ongoing recall by Luminex Corporation, reported 2021-05-05, distributed nationwide. Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used w
| Recall number | Z-1488-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2021-03-18 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, FR, GR, JP, NL, TR |
| Quantity | 1,210 units |
| Reason classes | microbial contamination |
| Pathogens | salmonella |
| UPC / GTIN / UDI-DI | 00840487101483, 00840487101490 |
| Serial numbers | 0902, 0907, 0908, 0909, 09098001, 09098002, 09098003, 09098005, 09098006, 09100008, 09100011, 09100012, 09100014, 0911, 0912, 09121015, 09121016, 09121018, 09121019, 09121022, 09135024, 09135026, 09135027, 09135028, 09135029 and 475 more |
| Model numbers | 10-0000-07, 10-0000-07R |
Product
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Reason for recall
Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1488-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.