Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 24, 2016
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate tra…
Bio-Rad Laboratories, Inc. recalled EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Ma… - a moderate-severity action.
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Ma… was recalled by Bio-Rad Laboratories, Inc. in February 24, 2016. Reason: The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system draw…. Check the official notice for the remedy. Verify recall #Z-0807-2016 with the FDA Devices before acting.
The recall
Bio-Rad Laboratories, Inc. issued this moderate-severity FDA Devices recall-The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system draw….
- Moderate
- severity level
- 278 units
- affected scope
- Class II
- classification
- February 24, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0807-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0807-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on December 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bio-Rad Laboratories, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 278 units.
The documented reason for this recall is: The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a conseq… Distribution data in the federal record shows the product reached: US Nationwide Distribution including Puerto Rico.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
278 units
Related Recalls
6
3 from same agency
Product description
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
Reason for recall
The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0807-2016 |
| Date reported | February 24, 2016 |
| Date initiated | December 22, 2015 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 278 units |
| Distribution | US Nationwide Distribution including Puerto Rico. |
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-0807-2016) 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? ▼
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 278 units.
Why was this product recalled? ▼
The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2016. Severity: Moderate. Recall number: Z-0807-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution including Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0807-2016) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 24, 2016. 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 July 2026.