AdvanDx E — Class II medical device recall Z-0116-2013
Terminated recall by Advandx Inc, reported 2012-10-31, distributed nationwide. Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa
| Recall number | Z-0116-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advandx Inc, Woburn, MA, United States |
| Recall initiated | 2012-09-14 |
| Classified | 2012-10-22 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 33 units |
| Reason classes | microbial contamination |
| Pathogens | e coli, pseudomonas |
| Lot numbers | 00512A-EU, 01812A-US, 03412A-US |
| Model numbers | KT007 |
| Expiration dates | 2013-12 |
Product
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Reason for recall
Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
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-0116-2013. 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.