Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 20, 2018
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.
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…
BioMerieux Sa recalled The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacter… — a moderate-severity action.
The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacter… was recalled by BioMerieux Sa in June 20, 2018. Reason: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Aft…. Check the official notice for the remedy. Verify recall #Z-2170-2018 with the FDA Devices before acting.
The recall
BioMerieux Sa issued this moderate-severity FDA Devices recall — A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Aft….
- Moderate
- severity level
- Class II
- classification
- June 20, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2170-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2170-2018) was formally reported on June 20, 2018, with the manufacturer initiating the action on March 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. BioMerieux Sa is listed as the recalling firm, operating out of Marcy L'Etoile, N/A. Federal records list the affected scope as FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches.
The documented reason for this recall is: 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 produc… Distribution data in the federal record shows the product reached: International distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2170-2018 |
| Date reported | June 20, 2018 |
| Date initiated | March 23, 2018 |
| Recalling firm | BioMerieux Sa |
| Firm location | Marcy L'Etoile, N/A |
| Affected scope | FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches |
| Distribution | International distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2170-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioMerieux Sa. Units affected: FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2170-2018.
Where was the recalled product distributed? ▼
Distribution: International distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2170-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 20, 2018.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.