The Recall Desk
HighFDA (Devices)·Z-0807-2016·Announced 2016-02-24

Bio-Rad EVOLIS Microplate System Recalled for Plate Transport Hazard

Bio-Rad is recalling 278 EVOLIS Microplate Systems because a low fluid alarm could cause the plate transport to continue running, pushing plates off the transporter.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure that could cause injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling 278 units of the EVOLIS Microplate System, Catalog # 89601. The product is a 4-plate fully integrated microplate processing system designed for use with multiple EIA assays. The recall covers units distributed nationwide in the United States, including Puerto Rico.

The recall was initiated due to a mechanical hazard. When the system alarmed for a low "Washer Reagent Clean Fluid" level, customers opened the system drawer. In these instances, the plate transport mechanism was still running, which caused the plate to be pushed off the plate transporter. The instrument is not lot controlled, but each unit is assigned a unique serial number for traceability.

Customers should check their serial numbers against the list provided in the official recall notice. If the serial number matches, the device should be taken out of service and the customer should contact Bio-Rad Laboratories for instructions on repair or replacement.

The recalled product

Product
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.
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
278

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • The EVOLIS Microplate System instrument is not lot controlled
  • 9163700175
  • 9163700187
  • 9163700196
  • 9163700208
  • 9163700210
  • 9163700231
  • 9163700266
  • 9163700278
  • 9163700320
  • 9163700328
  • 9163700336
  • 9163700337
  • 9163700349
  • 9163700354
  • 9163700368
  • 9163700402
  • 9163700431
  • 9163700449
  • 9163700478

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Bio-Rad Laboratories, Inc.

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Same hazard · mechanical hazard

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