The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram… — Class II medical device recall Z-2170-2018
Terminated recall by BioMerieux SA, reported 2018-06-20. A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Afte
| Recall number | Z-2170-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2018-03-23 |
| Classified | 2018-06-12 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-06-23 |
| Reason classes | temperature control |
| Lot numbers | F89544, G52306, G59407 |
| Model numbers | 29522, 29523, 29524 |
| Expiration dates | 2018-04-13, 2018-07-19, 2018-08-15 |
Product
The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
Reason for recall
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
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-2170-2018. 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.